DRAFTS IN WIDE CIRCULATION TECHNICAL COMMITTEE: MHD 02 DOCUMENT DESPATCH ADVICE Ref Date MHD 02/T-143, 144, 145, 146, 147 & 148 21-09-2012 ADDRESSED TO: 1. All members of Orthopaedic Instruments, Implants and Accessories Sectional Committee, MHD 02 2. All Members of Medical Equipment and Hospital Planning Division Council(MHDC) 3. All others interested Dear Madam(s)/Sir(s), Please find enclosed the following documents: Doc. No.: MHD 02(0277) /ISO 5832-1:2007 TITLE: Implants for Surgery Metallic materials Part 1: Wrought stainless steel [Superseding IS 5347(part 2):1993] Doc. No.: MHD 02(0278) /ISO 5832-2:1999 TITLE: Implants for Surgery Metallic materials Part 2: Unalloyed titanium [Superseding IS 5347(Part 3):1996] Doc. No.: MHD 02(0279) /ISO 5832-3:1996 TITLE: Implants for Surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4- vanadium alloy[superseding IS 5347(Part 4):1996] Doc. No.: MHD 02(0280) /ISO 5832-5:2005 TITLE: Implants for Surgery Metallic materials Part 5: Wrought cobalt-chromiumtungsten-nickel alloy[superseding IS 5347(Part 6):1996] Doc. No.: MHD 02(0281) /ISO 5832-8:1997 TITLE: Implants for Surgery Metallic materials Part 8: Wrought cobalt-nickel-chromiummolybdenum-tungsten-iron alloy[superseding IS 5347(Part 12):1993] Doc. No.: MHD 02(0282) /ISO 5832-9:2007 TITLE: Implants for Surgery Metallic materials Part 9: Wrought high nitrogen stainless steel[superseding IS 5347(Part 13):1997]
Kindly examine these draft standards 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: 31-12-2012 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. Thanking you, Yours sincerely, Encl: As above (Rakesh Kumar) Scientist F & Head (MHD) email:1) anurita@bis.org.in 2) mhd@bis.org.in Telefax: 011-23230910
Draft for Comments only Doc: MHD 02(0280) IS/ISO 5832-5:2005 [superseding IS 5347(Part 6):1996] BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Implants for Surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy Last date of receipt of comments is Orthopaedic Instruments Implant and Accessories Sectional Committee, MHD 02 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard ( Part 5 ) is identical with ISO 5832-5:2015 Implants for Surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy issued by the International Organization for Standardization (ISO). This draft Indian Standard was first published in 1984 as IS 5347(Part 6) based on ISO 5832-5:1978 and subsequently revised in 1996 to incorporate the modifications affected in the second edition of IS0 5832-5 brought out in 1993. It is now being published as IS/ISO 5832-5 to align with the latest ISO standard brought out in 2005. This draft Indian standard will supersede IS 5347(Part 6):1996 Requirements for orthopaedic implants Part 6: Wrought cobalt-chromium-tungsten-nickel alloy(first revision)and after the publication of this Draft Indian Standard, IS 5347(Part 6) shall be treated as withdrawn. No known surgical implant material has ever to be completely free of adverse reactions in the human body. However long-term clinical experience of the use of the material referred to in this draft standard has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications. 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 words International Standard appears 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. International Standard Title
ISO 643 ISO 4967:1998 ISO 6892 Steels-Micrographic determination of the apparent grain size Steel-Determination of content of nonmetallic inclusions- Micrographic method using standard diagrams Metallic materials-tensile testing at ambient temperature 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 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 the same as that of the specified value in this standard.
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 02(0280) /ISO 5832-5:2005 TITLE: Implants for Surgery Metallic materials Part 5: Wrought cobaltchromium-tungsten-nickel alloy LAST DATE OF COMMENTS: 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