SN EN ISO 10993-1 : 2010 CORR 2010

Current

Current The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

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Published date: 12-01-2013

Publisher: Swiss Standards

Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Terms and definitions
3 General principles applying to biological evaluation
  of medical devices
4 Categorization of medical devices
5 Testing
6 Selection of biological evaluation tests
7 Assurance of test methods
Annex A (informative) Rationale
Annex B (informative) Flow chart to aid in ensuring a
        systematic approach to biological evaluation of
        medical devices
Bibliography

Abstract - (Show below) - (Hide below)

Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.

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Committee	INB/NK 129
Development Note	Supersedes SN 119800. (06/2006) CORR 2010 is only available in English & French. (01/2015)
Document Type	Standard
ISBN
Pages
Published
Publisher	Swiss Standards
Status	Current
Supersedes	SN 119800 : 1990

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

Equivalent Standard(s)	Relationship
ONORM EN ISO 10993-1 : 2011	Identical
DIN EN ISO 10993-1:2010-04	Identical
NF EN ISO 10993-1 : 2010	Identical
UNI EN ISO 10993-1 : 2010	Identical
NS EN ISO 10993-1 : 2009 COR 2010	Identical
UNE-EN ISO 10993-1:2010	Identical
BS EN ISO 10993-1 : 2009-10	Identical
I.S. EN ISO 10993-1:2009+AC:2010	Identical
EN ISO 10993-1:2009/AC:2010	Identical

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