GSO ISO 20417:2023

ISO 20417:2021
Gulf Standard   Current Edition · Approved on 03 May 2023

Medical devices — Information to be supplied by the manufacturer

GSO ISO 20417:2023 Files

English 72 Pages
Current Edition Reference Language
231.66 USD

GSO ISO 20417:2023 Scope

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2.

This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.

NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.

Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

Best Sellers From Health Sector

GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
 
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2063:2023
 
Gulf Standard
Cosmetic Products - Hair Conditioner (Balsam)
GSO 1223:2023
 
Gulf Standard
Cosmetic Products-Deodorants

Recently Published from Health Sector

YSMO GSO 2061:2024
GSO 2061:2023 
Yemeni Standard
Cosmetic Products- Hair Fixative
GSO EN 14372:2024
EN 14372:2004 
Gulf Standard
Child use and care articles - Cutlery and feeding utensils - Safety requirements and tests
GSO ISO 10993-10:2024
ISO 10993-10:2021 
Gulf Standard
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
GSO ISO 21649:2024
ISO 21649:2023 
Gulf Standard
Needle-free injection systems for medical use — Requirements and test methods