SANS 13485 : 1ED 2004(R2011)

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View superseded by

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

Available format(s):

Superseded date: 30-09-2023

Language(s):

Published date: 23-11-2012

Publisher: South African Bureau of Standards

Abstract - (Show below) - (Hide below)

Defines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services, and aims to facilitate harmonized medical device regulatory requirements for quality management systems.

General Product Information - (Show below) - (Hide below)

Committee	TC 1039
Document Type	Standard
ISBN
Pages
Published
Publisher	South African Bureau of Standards
Status	Superseded
Superseded By	SANS 13485:2018

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 13485:2016	Identical

Categories associated with this Standard - (Show below) - (Hide below)

Sub-Categories associated with this Standard - (Show below) - (Hide below)

Sorry this product is not available in your region.

Add To Cart