DOCUMENT DESPATCH ADVICE DRAFT IN WIDE CIRCULATION MHR 06 /T- 50/51/52/53/ TECHNICAL COMMITTEE: MHR 06

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1 DRAFT IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHR 06 DOCUMENT DESPATCH ADVICE Ref Date MHR 06 /T- 50/51/52/53/ DOC NO: MHR 06 (0114)/ISO 7199:1996 TITLE Cardiovascular implants and artificial organs-blood-gas exchangers (Oxygenators) DOC NO: MHR 06 (0115)/ISO 13960:2003 TITLE Cardiovascular implants and artificial organs-plasmafilters DOC NO: MHR 06 (0116)/ISO 15674:2001 TITLE Cardiovascular implants and artificial organs-hard-shell Cardiotomy/ venous reservoir system (with/without filter) and soft venous reservoir bags DOC NO: MHR 06 (0117) ISO :2003 TITLE Cardiovascular implants -Endovascular Devices Part 1 Endovascular prostheses DOC NO: MHR 06 (0118) ISO15539:2000 TITLE Cardiovascular implants- Endovascular prostheses Kindly examine the draft National forward your views stating any difficulties which you are likely to experience in your business or profession, if this is finally adopted as National Standards. Last date for comments: Comments if any may please be made in the format enclosed and mailed to the undersigned 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 of comments of technical in 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. Thanking you, Yours faithfully, Encl: As Above ( Rahul Kumar ) Scientist F & Head (MHD) Note The above mention document are not available in website, only National forward are available. So please refer ISO doc as mention above, therefore if any quarries related to document please contact above mention address.

2 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/subclauses/table/fig. etc be started on a fresh box. Information in Column 5 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: MHR 06 (0114)/ISO 7199:1996 TITLE Cardiovascular implants and artificial organs-blood-gas exchangers (Oxygenators) DOC NO: MHR 06 (0115)/ISO 13960:2003 TITLE Cardiovascular implants and artificial organs-plasmafilters DOC NO: MHR 06 (0116)/ISO 15674:2001 TITLE Cardiovascular implants and artificial organs-hard-shell Cardiotomy/ venous reservoir system (with/without filter) and soft venous reservoir bags DOC NO: MHR 06 (0117) ISO :2003 TITLE Cardiovascular implants -Endovascular Devices Part 1 Endovascular prostheses DOC NO: MHR 06 (0118) ISO15539:2000 TITLE Cardiovascular implants- Endovascular prostheses LAST DATE OF COMMENTS: NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Sublause para/table/fig. Commentator Orgn (Abbreviation) Comments Justification & Proposed change

3 Draft for comments only Doc. MHR 06 (0114) ISO: 7199:1996 Draft Indian Standard Cardiovascular implants and artificial organs-blood-gas exchangers (Oxygenators) ICS NO Not to be produced without the permission of BIS Last Date of Comments: 11:08:2008 or used as a Standard Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR National Forward: (Formal Clause will be added later) This Draft Indian Standard is identical with ISO 7199:1996 Cardiovascular implants and artificial organs- Blood-gas exchangers (Oxygenators) issued by this International Organization for Standardization (ISO) will adopted by the Bureau of Indian Standards on the recommendation of the Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR 06 and approval of the Medical Equipment and Hospital Planning Department This Draft Indian Standard is intended to ensure that devices designed to effect the exchange of gases in support of or as a substitution for, the normal respiratory function of the lungs have been adequately tested for both their safety and function, and that extracorporeal devices characteristics are appropriately disclosed when labelling the devices. This Draft Indian Standard therefore contains recommended procedures to be used for evaluation of extracorporeal blood-gas exchangers (oxygenators). Type-test procedures for determination of the gas transferm blood cell damage and heat exchanger performance of such devices are described although limits for these characteristics are not specified. Ready identification of the performance characteristics should, however, assist the user in the in the selection of an exygenator which will suit the need of the patient. This Draft Indian Standard also includes minimum reporting requirements which will allow the user to compare performance characteristics oxygenators of different designs in a standard way. This Draft Indian Standard make reference to other International Standards in which methods for determination of characteristic common to medical devices can be found. No provisions have been made for quantification of micro bubble generation nor for nonformed elements of abovine blood, due to the fact that there is currently no consensus regarding satisfactorily reproducible test methods. Requirements for animal and clinical studies have not been included in this Draft Indian Standard. such studies may be part manufacturer s quality system.

4 This Draft Indian Standard contains only those requirements that are specific to oxygenators. Non specific requirements are covered by references to other International Standards listed in the normative references section since nontoxicity is anticipated to be the subject of a future horizontal/level 1 standrd, this International Standard does not cover nontoxicity. The text of the 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 word 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. Cross References In this adopted standard, reference appears to certain International Standards for which Indian standard also exist. the corresponding Indian Standard which are to be substituted in their place are listed below along with their degree of equivalence the editions indicated: International Standards ISO Biological evaluation of medical devices- Part 1: Evaluation and testing ISO 13485, Quality systems- Medical devices Particular requirements for the application of ISO 9001 Corresponding Indian Standard IS :1994 Biological evaluation of medical devices- Part 1 Guidance on selection of Tests IS 15579: 2005 Medical Device Quality Management System-Requirement for regulatory purposes Degree of Equivalence The technical committee responsible for the preparation of this standard has reviewed the provision of the following ISO standards and has decided that they are acceptable for use in conjunction with this standard ISO Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals ISO Biological evaluation of medical devices- Part 11 Tests for systemic toxicity ISO 11134, Sterilization of health care products- Requirements of validation and routine control-moist heat sterilization ISO 11135, Medical devices validation and routine control of ethylene oxide sterilization ISO11137 Sterilization of health care products-requirements for validation and routine control- Radiation sterilization ISO 13488, Quality Systems- Medical devices Particular requirements for the application of ISO 9002 For the purpose of deciding whether a particular requirement of this standard is complied with, the final valve, 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

5 signified places retained in the rounded off valve should be the same as that of the specified valve in this standard. Draft for comments only Doc. MHR 06 (0115) ISO: 13960:2003 Draft Indian Standard Cardiovascular implants and artificial organs-plasmafilters ICS NO Not to be produced without the permission of Last Date of Comments: 11:08:2008 BIS or used as a Standard Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR National Forward: (Formal Clause will be added later) This Draft Indian Standard is identical with ISO 13960: 2003 Cardiovascular implants and artificial organs-plasma filters issued by the International Organization for Standardization (ISO) will adopted by the Bureau of Indian Standards on the recommendation of the Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR 06 and Approval of the Medical Equipment and Hospital Planning Department This Draft Indian Standard contains requirements and acceptance criteria (including test methods) for safety related parameters for plasma filters. Only those requirements that are specific to plasma filters have been included. Non-specific requirements are covered by reference to other International Standards, listed in the normative references clauses. This Draft Indian Standard does not address matters related to toxicity. Such issues are covered in the relevant part of IS 12572(Part 1):1994. The text of the 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: c) Wherever the word International Standard appear referring to this standard, they should be read as Indian Standard d) Comma (.) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. Cross References In this adopted standard, reference appears to certain International Standards for which Indian standard also exist. The corresponding Indian Standard which are to be substituted in their place are listed below along with their degree of equivalence the editions indicated: International Standards Corresponding Indian Standard Degree of Equivalence

6 ISO Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment-part 2 Lock fittings ISO Biological evaluation of medical devices- Part 1: Evaluation and testing ISO 13485, Quality systems- Medical devices Particular requirements for the application of ISO 9001 IS 3234 : Part 1 : 1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements IS : Part 1 : 1994 Biological Evaluation of Medical Devices - Part 1 : Guidance on Selection of Tests IS 15579: 2005 Medical Device Quality Management System-Requirement for regulatory purposes The technical committee responsible for the preparation of this standard has reviewed the provision of the following ISO standards and has decided that they are acceptable for use in conjunction with this standard ISO 8637, cardiovascular implants and artificial organs-haemodialysers, haemodiafilters, haemodifilters and haemoconcentrators ISO Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals ISO Biological evaluation of medical devices- Part 11 Tests for systemic toxicity ISO 11134, Sterilization of health care products- Requirements of validation and routine control-moist heat sterilization ISO 11135, Medical devices validation and routine control of ethylene oxide sterilization ISO11137 Sterilization of health care products-requirements for validation and routine control-radiation sterilization ISO 13488, Quality Systems- Medical devices Particular requirements for the application of ISO 9002 For the purpose of deciding whether a particular requirement of this standard is complied with, the final valve, 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 signified places retained in the rounded off valve should be the same as that of the specified valve in this standard.

7 Draft for comments only Doc. MHR 06 (0116) ISO: 15674:2001 Draft Indian Standard Cardiovascular implants and artificial organs-hard-shell Cardiotomy/ venous reservoir system (with/without filter) and soft venous reservoir bags ICS NO Not to be produced without the permission of BIS Last Date of Comments: 11:08:2008 or used as a Standard Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR National Forward: (Formal Clause will be added later) This Draft Indian Standard is identical with ISO : 2001 Cardiovascular implants and artificial organs- Hard shell Cardiotomy/ venous reservoir system (with/without filter) and soft venous reservoir bags issued by the International Organization for Standardization (ISO) will adopted by the Bureau of Indian Standards on the recommendation of the Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR 06 and Approval of the Medical Equipment and Hospital Planning Department This Draft Indian Standards applies only to the blood reservoir aspect for multifunctional system which may have integral components such as blood-gas exchangers (oxygenators), blood filters, deformers, blood pumps, etc. The text of the 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: e) Wherever the word International Standard appear referring to this standard, they should be read as Indian Standard f) Comma (.) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. Cross References In this adopted standard, reference appears to certain International Standards for which Indian standard also exist. The corresponding Indian Standard which are to be substituted in their place are listed below along with their degree of equivalence the editions indicated: International Standards ISO Biological evaluation of medical devices- Part 1: Evaluation and testing ISO 13485, Quality systems- Medical devices Particular Corresponding Indian Standard IS :1994 Biological evaluation of medical devices- Part 1 Guidance on selection of Tests IS 15579: 2005 Medical Device Quality Management Degree of Equivalence

8 requirements for the application of ISO 9001 System-Requirement for regulatory purposes The technical committee responsible for the preparation of this standard has reviewed the provision of the following ISO standards and has decided that they are acceptable for use in conjunction with this standard ISO Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals ISO Biological evaluation of medical devices- Part 11 Tests for systemic toxicity ISO 11134, Sterilization of health care products- Requirements of validation and routine control-moist heat sterilization ISO 11135, Medical devices validation and routine control of ethylene oxide sterilization ISO11137 Sterilization of health care products-requirements for validation and routine control- Radiation sterilization ISO 11607, Packaging for terminally sterilized medical devices ISO 13488, Quality Systems- Medical devices Particular requirements for the application of ISO 9002 ISO Sterilization of medical devices-general requirements of characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices For the purpose of deciding whether a particular requirement of this standard is complied with, the final valve, 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 signified places retained in the rounded off valve should be the same as that of the specified valve in this standard.

9 Draft for comments only Doc. MHR 06 (0117) ISO: :2003 Draft Indian Standard Cardiovascular implants -End vascular Devices Part 1 Endovascular prostheses ICS NO Not to be produced without the permission of Last Date of Comments: 11:08:2008 BIS or used as a Standard Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR National Forward: (Formal Clause will be added later) This Draft Indian Standard is identical with ISO :2003 Cardiovascular implants - Endovascular Devices Part 1 Endovascular prostheses issued by this International Organization for Standardization (ISO) will adopted by the Bureau of Indian Standards on the recommendation of the Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR 06 and approval of the Medical Equipment and Hospital Planning Department. It is impossible to take into consideration all future and emerging technologies. These emerging-tecnology prostheses will needs to follow the basic test protocols of this part of Draft Indian Standard to characterize the endovascular system. Testing beyond the scope of this part of Draft Indian Standard may also be necessary to characterize new emerging-technology prostheses. Consideration shall give to the failure modes of the prostheses and their effects on the performance of the implant in identifying the appropriate testing. If the compound prosthesis is partially constructed of a resorbable component, the non-resorbable portion of the implant shall be characterized as well as the implant as a whole. The text of the 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: g) Wherever the word International Standard appear referring to this standard, they should be read as Indian Standard h) Comma (.) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. Cross References In this adopted standard, reference appears to certain International Standards for which Indian standard also exist. The corresponding Indian Standard which are to be substituted in their place are listed below along with their degree of equivalence the editions indicated: International Standards Corresponding Indian Standard Degree of Equivalence ISO Biological evaluation of medical devices- Part 1: Evaluation and testing IS :1994 Biological evaluation of medical devices- Part 1 Guidance on selection of

10 ISO 13485, Quality systems- Medical devices Particular requirements for the application of ISO 9001 Tests IS 15579: 2005 Medical Device Quality Management System- Requirement for regulatory purposes The technical committee responsible for the preparation of this standard has reviewed the provision of the following ISO standards and has decided that they are acceptable for use in conjunction with this standard ISO 7198:1998 Cardiovascular implants- Tubular vascular prostheses ISO 11134, Sterilization of health care products- Requirements of validation and routine control-moist heat sterilization ISO 11135, Medical devices validation and routine control of ethylene oxide sterilization ISO11137 Sterilization of health care products-requirements for validation and routine control- Radiation sterilization ISO ( all Parts) Biological evaluation of medical devices ISO 11607, Packaging for terminally sterilized medical devices ISO 13488, Quality Systems- Medical devices Particular requirements for the application of ISO 9002 ISO (all parts) Clinical Investigation of medical device for human subjects ISO Sterilization of single- use medical devices incorporating materials of animal origin- Validation and routine control of sterilization by liquid chemical sterilants ISO 14630:1997 Non-active surgical implants General requirements ISO Sterilization of medical devices-general requirements of characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices ISO Medical devices-application of Risk Management to Medical Device For the purpose of deciding whether a particular requirement of this standard is complied with, the final valve, 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 signified places retained in the rounded off valve should be the same as that of the specified valve in this standard.

11 Draft for comments only Doc. MHR 06 (0118 ) ISO/TS: 15539:2000 Draft Indian Standard Cardiovascular implants- Endovascular prostheses ICS NO Not to be produced without the permission of Last Date of Comments:11:08:2008 BIS or used as a Standard Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR National Forward: (Formal Clause will be added later) This Draft Indian Standard is identical with ISO/TS 15539: 2000 Cardiovascular implants- Endovascular prostheses issued by the International Organization for Standardization (ISO) will adopted by the Bureau of Indian Standards on the recommendation of the Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHR 06 and approval of the Medical Equipment and Hospital Planning Department. This Technical Specification, In addition to ISO 14630, provides a method to demonstrate compliance with the relevant recommendations as outlined concerning medical devices, as they apply to a family of cardiovascular devices. The text of the 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: i) Wherever the word International Standard appear referring to this standard, they should be read as Indian Standard j) Comma (.) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. Cross References In this adopted standard, reference appears to certain International Standards for which Indian standard also exist. The corresponding Indian Standard which are to be substituted in their place are listed below along with their degree of equivalence the editions indicated: International Standards ISO 13485, Quality systems- Medical devices Particular requirements for the application of ISO 9001 Corresponding Indian Standard IS 15579: 2005 Medical Device Quality Management System-Requirement for regulatory purposes Degree of Equivalence

12 The technical committee responsible for the preparation of this standard has reviewed the provision of the following ISO standards and has decided that they are acceptable for use in conjunction with this standard ISO 11134, Sterilization of health care products- Requirements of validation and routine control-moist heat sterilization ISO 11135, Medical devices validation and routine control of ethylene oxide sterilization ISO11137 Sterilization of health care products-requirements for validation and routine control-radiation sterilization ISO 11607, Packaging for terminally sterilized medical devices ISO 13488, Quality Systems- Medical devices Particular requirements for the application of ISO 9002 ISO Sterilization of single- use medical devices incorporating materials of animal origin-validation and routine control of sterilization by liquid chemical sterilants. ISO 14630:1997 Non-active surgical implants General requirements ISO Sterilization of medical devices-general requirements of characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices ISO Medical devices-risk Management-Part 1: Application of risk analysis EN 556, Sterilization of medical devices-requirements for terminally sterilized devices to be labeled sterile For the purpose of deciding whether a particular requirement of this standard is complied with, the final valve, 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 signified places retained in the rounded off valve should be the same as that of the specified valve in this standard.