DRAFTS IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE MHD 10/ T- 2,3,41,33,43,44,45,46,47,48 10/02/2015 TECHNICAL COMMITTEE: MHD 10

Transcription

1 DRAFTS IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHD 10 DOCUMENT DESPATCH ADVICE Ref Date MHD 10/ T- 2,3,41,33,43,44,45,46,47,48 10/02/2015 ADDRESSED TO: 1. All members of Medical Laboratory Instruments Sectional Committee, MHD All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Madam/Sir(s), Please find enclosed the following documents: DOC NO: MHD 10(371)/ ISO :2009 TITLE : Injection containers and accessories- Part1 : Injection vials made of glass tubing DOC NO: MHD 10(372)/ISO :2011 TITLE : : Injection containers and accessories- Part 4: Injection vials made of moulded glass DOC NO: MHD 10(373)/ISO :2010 TITLE : Injection equipment for medical use- Part1 : Ampoules for injectables DOC NO: MHD 10(374)/ISO 6710:1995 TITLE : Single-use containers for venous blood specimen collection DOC NO: MHD 10(375)/ISO :2011 TITLE : Infusion equipment for medical use- Part1 : Infusion glass bottles DOC NO: MHD 10(376)/ISO :1992 TITLE : Prefilled syringes- Part1: Glass cylinders for dental local anesthetic cartridges DOC NO: MHD 10(377)/ISO : 2011 TITLE : Prefilled syringes - Part 2: Plunger stoppers for dental local anesthetic cartridges DOC NO: MHD 10(378)/ISO :2012 TITLE : Prefilled syringes - Part 3: Seals for dental local anesthetic cartridges DOC NO: MHD 10(379)/ISO :2007 TITLE : Prefilled syringes - Part 4: Glass barrels for injectables DOC NO: MHD 10(380)/ISO :2012 TITLE : Prefilled syringes - Part 5: Plunger stoppers for injectables

2 Kindly examine the draft standard and forward your views stating any difficulties, which you are likely to experience in your business or profession, if these are finally adopted as National Standard. Last date for comments: 15/05/2015 Comments if any, may please be made in the format indicated and mailed to the undersigned at the above address. In case no comments are received or comments received are of editorial nature, you will kindly permit us to presume your approval for the above document as finalized. However, in case comments of technical nature are received then it may be finalized either in consultation with the Chairman, Sectional Committee or referred to the Sectional committee for further necessary action if so desired by the Chairman, Sectional Committee. Encl: As above Thanking you, Yours sincerely, (S. Kishore Kumar) Scientist F & Head (MHD) Bureau of Indian Standards 9, B. S. Zafar Marg New Delhi ) hmhd@bis.org.in 2) mhd@bis.org.in Telefax:

3 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (371)/ISO :2009 TITLE : Injection containers and accessories- Part1: Injection vials made of glass tubing LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

4 Draft for Comments only Doc No: MHD 10 (371) ISO :2009 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Injection containers and accessories- Part1: Injection vials made of glass tubing (first revision) Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO Injection containers and accessories- Part1: Injection vials made of glass tubing issued by the International Organization for Standardization. This standard was first published in 2003 as IS based on ISO : 2003 which has been revised in This revision is being taken to align it with the latest international practices. The purpose of this part of ISO 8362 is to specify the dimensions, capacities, form and requirements of glass vials intended for medical use. Containers made from glass tubing are considered to be suitable for the packaging and storage of injectable preparations until they are administered for medicinal purposes. Such containers may be made from different types of glass which can affect the chemical resistance properties; e.g., those made from borosilicate glass will have a very high level of chemical resistance whereas others made from soda-lime glass will have a lower, but adequate, chemical resistance for the purpose for which they are intended. The chemical resistance of the internal surface of containers made from soda-lime glass can be improved by means of a treatment during production aimed at producing a chemical resistance equal to that of those made from borosilicate glass for single use. This level of chemical resistance is maintained as long as the interior surface is not destroyed by chemical attack, in which case it is reduced to that of untreated soda-lime glass. Because containers may be made from different types of glass and because it is the chemical behaviour of the internal surface which is important when they are filled with injectable preparations, it is essential to specify test procedures by which this performance can be measured. The procedures recommended in this part of ISO 8362 permit this performance, based on the hydrolytic resistance to be measured and, from the result of measurement, it is possible to classify containers into their correct category. The procedure also allows containers to be tested and to determine, after an intermediate stage, whether the hydrolytic resistance is produced by the composition of the glass as a material or by a treatment of the internal surface. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following:

5 a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO , Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification IS 2303 (Part 1/Sec 1) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 1 Hydrolytic Resistance of Glass Grains at 98 C ( Second Revision ) IS 2303 (Part 1/Sec 2) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C ( Second Revision ) IS 2303 ( Part 2 ) : 1994 Grading Glass For Alkalinity Part 2 Hydrolytic Resistance of Glass Containers ( First Revision) Identical Identical Technical Equivalent The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO 1101 ISO Title Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

6 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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9 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (372)/ISO :2011 TITLE : Injection containers and accessories- Part 4: Injection vials made of moulded glass LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

10 Draft for Comments only Doc No: MHD 10 (372) ISO :2011 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Injection containers and accessories- Part4: Injection vials made of moulded glass (first revision) Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2011 Injection containers and accessories- Part 4: Injection vials made of moulded glass issued by the International Organization for Standardization. This standard was first published in 2003 as IS based on ISO :1989 which has been revised in This revision is being taken to align it with the latest international practices. The purpose of this part of ISO 8362 is to specify the shape, dimensions and capacities of, and performance requirements for, glass vials intended for medical use. Containers made from moulded glass are considered to be suitable for the packaging and storage of injectable preparations until they are administered for medicinal purposes. Such containers can be made from different types of glass, which can affect the chemical resistance properties. For example, those made from borosilicate glass will have a very high level of chemical resistance, whereas those made from soda-lime-silica glass will have a lower chemical resistance but one that is adequate for the purpose for which the containers are intended. The chemical resistance of the internal surface of containers made from soda-lime-silica glass can be improved by a treatment during production to produce a chemical resistance equal to that of containers made from borosilicate glass for single use. This level of chemical resistance will be maintained as long as the interior surface is not destroyed by chemical attack, in which case it will be reduced to that of untreated soda-lime-silica glass. Because containers can be made from different types of glass and because it is the chemical behavior of the internal surface that is important when they are filled with injectable preparations, it is essential to specify test procedures by which this performance can be measured. The procedures specified in this part of ISO 8362 will allow this performance based on the hydrolytic resistance to be measured and, from the result of measurement, it is possible to classify containers into their correct category. The procedures also allow containers to be tested and to determine whether the hydrolytic resistance is due to the composition of the glass, or to a treatment of the internal surface The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard.

11 b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO , Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO 7458, Glass containers Internal pressure resistance Test methods ISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methods IS 2303 (Part 1/Sec 1) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 1 Hydrolytic Resistance of Glass Grains at 98 C ( Second Revision ) IS 2303 (Part 1/Sec 2) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C ( Second Revision ) IS 2303 ( Part 2 ) : 1994 Grading Glass For Alkalinity Part 2 Hydrolytic Resistance of Glass Containers ( First Revision) IS : Methods of Test for Internal Pressure Resistance of Glass Containers IS: Methods of Thermal Shock Tests for Glass Containers Identical Identical Technical Equivalent Technical Equivalent Technical Equivalent The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO Title Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

12 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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15 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (373)/ISO :2010 TITLE : Injection equipment for medical use - Part1: Ampoules for injectables LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

16 Draft for Comments only Doc No: MHD 10 (373) ISO :2010 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Injection equipment for medical use - Part1: Ampoules for injectables (first revision) Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2010 Injection equipment for medical use - Part1: Ampoules for injectables issued by the International Organization for Standardization. This standard was first published in 2004 as IS based on ISO :2000 which has been revised in This revision is being taken to align it with the latest international practices. Ampoules are suitable packaging materials for storing pharmaceutical products until they are administered to the patient. Owing to the direct contact between injectables and the primary container over extended storage periods, possible interactions are to be avoided in order to guarantee patient safety. Adequate means to achieve this objective include proper selection of primary packaging materials, the choice of suitable package design and the availability of specific requirements and methods for testing individual container systems. In the past, four standardized forms of ampoule (forms A, B, C and D) have been in widespread use. However, form A is no longer used in the pharmaceutical industry and consequently has not been included in this part of ISO To avoid any confusion among manufacturers and users, it was decided to retain the same designation letters (i.e. B, C and D) for the forms of ampoules in current use and to disregard the letter A. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated:

17 International Standards Corresponding Indian Standards Degree of Equivalence ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO , Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO , Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO , Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration of the force-measuring system IS 2303 (Part 1/Sec 2) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C ( Second Revision ) IS 2303 ( Part 2 ) : 1994 Grading Glass For Alkalinity Part 2 Hydrolytic Resistance of Glass Containers ( First Revision) IS 2500 (Part 1) :2000 Sampling Procedure For Inspection By Attributes Part 1 Sampling Schemes Indexed By Acceptance Quality Limit (AQL) For Lot-By-Lot Inspection (Third Revision) IS 1828 (Part 1) :2005 Metallic Materials Verification of Static Uniaxial Testing Machines Part 1 Tension/Compression Testing Machines Verification And Calibration of the Force-Measuring System ( Third Revision) Identical Technical Equivalent Identical Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO Title Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

18 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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21 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (374)/ISO 6710:1995 TITLE : Single-use containers for venous blood specimen collection LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

22 Draft for Comments only Doc No: MHD 10 (374) ISO 6710:1995 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Single-use containers for venous blood specimen collection (first revision) Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO 6710:1995 Single-use containers for venous blood specimen collection issued by the International Organization for Standardization. This standard was first published in 1984 as IS based on ISO 4822:1981 which has been revised by ISO 6710:1995. This revision is being taken to align it with the latest international practices. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence IS0 594-l : 1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part I : General requirements IS:3234(Part1):l986 Specification for Conical Fittings with a 6 Percent ( Luer ) Taper For Syringes, Needles And Other Medical Equipment Part 1 General Requirements (Second Revision) Identical

23 The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO 3696: 1987 IS0 7000: 1989 Title Water for analytical laboratory use -Specification and test methods Graphical symbols for use on equipment - Index and synopsis For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

24 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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27 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (375)/ISO :2011 TITLE : Infusion equipment for medical use - Part1 : Infusion glass bottles LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

28 Draft for Comments only Doc No: MHD 10 (371) ISO :2011 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Infusion equipment for medical use- Part1 : Infusion glass bottles Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2011 Infusion equipment for medical use- Part1 : Infusion glass bottles issued by the International Organization for Standardization. Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they are administered to the patient. Due to the direct contact between infusion solution and the primary container components and in view of the extended storage periods, it is essential to avoid possible interactions in order to guarantee the patient's safety. Adequate means to achieve this goal include the proper selection of the primary packaging materials, the choice of suitable package design and the availability of specific criteria and methods for testing of individual container systems. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence ISO 719, Glass Hydrolytic resistance of glass grains at 98 C IS 2303 (Part 1/Sec 1) : 2012 Grading Glass Part 1 Method Of Test And Identical Method of test and Classification Section 1 Hydrolytic classification Resistance of Glass Grains at 98 C ( Second Revision ) ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification IS 2303 (Part 1/Sec 2) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C ( Second Revision ) Identical

29 ISO , Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO 7458, Glass containers Internal pressure resistance Test methods ISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methods IS 2303 ( Part 2 ) : 1994 Grading Glass For Alkalinity Part 2 Hydrolytic Resistance of Glass Containers ( First Revision) IS : Methods of Test for Internal Pressure Resistance of Glass Containers IS: Methods of Thermal Shock Tests for Glass Containers Technical Equivalent Technical Equivalent Technical Equivalent The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO Title Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

30 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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33 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (376)/ISO :1992 TITLE : Prefilled Syringes- Part 1: Glass cylinders for dental local anesthetic cartridges LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

34 Draft for Comments only Doc No: MHD 10 (376) ISO :1992 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Prefilled Syringes- Part 1: Glass cylinders for dental local anesthetic cartridges Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :1992 Prefilled Syringes- Part 1: Glass cylinders for dental local anesthetic cartridges issued by the International Organization for Standardization. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO , Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification IS 2303 (Part 1/Sec 2) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C ( Second Revision ) IS 2303 ( Part 2 ) : 1994 Grading Glass For Alkalinity Part 2 Hydrolytic Resistance of Glass Containers ( First Revision) Identical Technical Equivalent

35 The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO : 1988 Title Glassware - Hydrolytic resistance of the interior surfaces of glass Containers - Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

36 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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38 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (377)/ISO :2011 TITLE : Prefilled Syringes - Part 2: Plunger stoppers for dental local anesthetic cartridges LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

39 Draft for Comments only Doc No: MHD 10 (377) ISO :2011 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Prefilled Syringes - Part 2: Plunger stoppers for dental local anesthetic cartridges Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2011 Prefilled Syringes - Part 2: Plunger stoppers for dental local anesthetic cartridges issued by the International Organization for Standardization. Primary packaging components made of elastomeric materials are an integral part of medicinal products. As such, the principles of current Good Manufacturing Practices (cgmp) are applicable to the manufacturing of these components. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence ISO 48 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) ISO , Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: IS 3400 (Part 2) : 2014 Methods of Test for Vulcanized Rubber Part 2 Rubber, Vulcanized or Thermoplastic Determination of Hardness (Hardness Between 10 IRHD and 100 IRHD) ( Fourth Revision ) IS 3400 (Part 23): 2002 Methods of Test for Vulcanized Rubbers Part 23: Rubber Determination of Identical Identical with ISO 7619:1997 Rubber Determination of

40 Durometer method (Shore hardness) Indentation Hardness By Means of Pocket Hardness Meters indentation hardness by means of pocket hardness meters The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO 3302 (all parts) Title Rubber Tolerances for products ISO ISO ISO ISO Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges Prefilled syringes Part 3: Seals for dental local anaesthetic cartridges For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

41 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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44 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (378)/ISO :2012 TITLE : Prefilled Syringes - Part 3: Seals for dental local anesthetic cartridges LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

45 Draft for Comments only Doc No: MHD 10 (378) ISO :2012 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Prefilled Syringes - Part 3: Seals for dental local anesthetic cartridges Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2012 Prefilled Syringes - Part 3: Seals for dental local anesthetic cartridges issued by the International Organization for Standardization. Primary packaging components made of elastomeric materials are an integral part of medicinal products. Therefore, the principles of current good manufacturing practices (cgmp) apply to the manufacturing of these components. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards Degree of Equivalence ISO Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) IS 3400 (Part 23): 2002 Methods of Test for Vulcanized Rubbers Part 23: Rubber Determination of Indentation Hardness By Means of Pocket Hardness Meters Identical with ISO 7619:1997 Rubber Determination of indentation hardness by means of pocket hardness meters The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard:

46 International Standard/ Other publications Title ISO ISO 7885:2010 Rubber Tolerances for products Part 1: Dimensional tolerances Dentistry Sterile dental injection needles for single use ISO Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates ISO Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods ISO :2005 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing ISO 8872 ISO ISO Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

47 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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50 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (379)/ISO :2007 TITLE : Prefilled Syringes - Part 4: Glass Barrels for injectables LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

51 Draft for Comments only Doc No: MHD 10 (379) ISO :2007 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Prefilled Syringes - Part 4: Glass Barrels for injectables Last date of receipt of comments is 15/05/2015 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2007 Prefilled Syringes - Part 4: Glass Barrels for injectables issued by the International Organization for Standardization. For the parenteral use of liquid pharmaceutical products, at present ampoules and injection vials are mainly used. However, for the injection of the liquid pharmaceutical products contained in those vials, a hypodermic syringe combined with the appropriate injection needle is also needed. This means the liquid pharmaceutical product has to be transferred to the hypodermic syringe before its final use. This procedure is not only time consuming, but also presents a great number of possibilities for contamination. To ensure safe use of a liquid pharmaceutical product, prefilled syringes for single use are already on the market. Without doubt, such prefilled syringes permit immediate injection of the product contained after relatively simple handling. Based on diameter of the prefilled syringes, appropriate components, such as rubber plungers and aluminium caps, can also be standardized. The producers of filling machines can apply this part of ISO to achieve a degree of standardization in the equipment of the machines. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated:

52 International Standards Corresponding Indian Standards Degree of Equivalence IS0 594-l Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part I : General requirements ISO Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO , Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1:Determination by titration method and classification IS:3234(Part1):l986 Specification for Conical Fittings with a 6 Percent ( Luer ) Taper For Syringes, Needles And Other Medical Equipment Part 1 General Requirements (Second Revision) IS 3234(Part2):1995 Conical Fltttngs With a 6% (Luer) Taper For Syringes, Needles and Certain Other Medical Equipment Part 2 Lock Fittings IS 2303 (Part 1/Sec 2) : 2012 Grading Glass Part 1 Method Of Test And Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C ( Second Revision ) IS 2303 ( Part 2 ) : 1994 Grading Glass For Alkalinity Part 2 Hydrolytic Resistance of Glass Containers ( First Revision) Identical Identical Identical Technical Equivalent The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications ISO Title Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

53 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

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56 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (380)/ISO :2012 TITLE : Prefilled Syringes - Part 5: Plunger stoppers for injectables LAST DATE OF COMMENTS: 15/05/2015 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change