IS 19193 : 2025 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee-Joint Replacement Implants (ISO 21536 : 2023, MOD)
(Superseding IS/ISO 21536 : 2007)
NATIONAL FOREWORD
This Indian Standard which is modified adoption of ISO 21536 : 2023 'Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants' issued by the International Organization for Standardization was adopted by the Bureau of Indian Standards on the recommendation of the Orthopaedic Instruments, Implants and Accessories Sectional Committee and after approval of the Medical Equipment and Hospital Planning Division Council.
This standard supersedes IS/ISO 21536 which was first published in 2018 and was identical to ISO 21536 : 2007 'Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants'. This revision has been brought out to align it with the latest version of ISO 21536 : 2023.
The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and conventions are, however, not identical to those used in 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'; and
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.