IS/ISO 5838 : Part 1 : 2013 Implants for Surgery - Metallic Skeletal Pins and Wires Part 1 General Requirements

ICS 11.040.40

MHD 02

Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with ISO 5838-1 : 2013 ‘Implants for surgery — Metallic skeletal pins and wires — Part 1: General requirements’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Orthopaedic Instruments Implant and Accessories Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was originally published in 1984 as IS 8261 (Part 4) by adoption of ISO 5838-1 : 1995 under the dual numbering system and subsequently revised in 1998 to align it with ISO 5838-1 : 1995. This standard has been prepared by adoption of ISO 5838-1 : 2013 under the single numbering system. This standard supersedes IS 8261 (Part 4) : 1998 ‘Pins and wires skeletal traction: Part 4 Material and mechanical requirements (first revision)’.

This standard incorporates the modifications effected to add to:

a) the requirements for finish (Clause 6);

b) a reference to ISO 14630 : 2012; and

c) introduce new requirements for sterilization (Clause 7), packaging (Clause 8) and information supplied by the manufacturer (Clause 9).

The text of the 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 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 Standard, the current practice is to use a point (.) as the decimal marker.