EN 30993-1 : 1994

Name: EN 30993-1 : 1994
Brand: CEN

Superseded

View Superseded by

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS

Superseded date

21-03-2022

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

Cooperating organizations
National foreword
Foreword
Introduction
Guide
1. Scope
2. Normative references
3. Definitions
4. General principles applying to biological
     evaluation of materials and devices
5. Categorization of medical devices
6. Testing
7. Guidance on selection of biological evaluation
     tests
8. Assurance of test methods
Annexes
A. (informative) Rationale
B. (informative) Bibliography of international and
     national standards and regulations
Tables
1. Guidance for initial evaluation tests
2. Guidance for supplementary evaluation tests
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-references

Gives advice on the fundamental principles governing the biological evaluation of medical devices; and the selection of appropriate tests. Also helps with the definition of categories of devices based on the nature and duration of contact with the body. Also gives detailed definitions, tables and annexes.

DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 10993-1:2020

Standards	Relationship
ISO 10993-1:2009	Similar to
UNE-EN 30993-1:1994	Identical
BS EN 30993-1:1994	Identical
NEN ISO 10993-1 : 1994	Identical
UNI EN 30993-1 : 1995	Identical
NF EN 30993-1 : 1994	Identical
NBN EN 30993-1 : 1995	Identical
I.S. EN 30993-1:1995	Identical
DIN EN 30993-1:1994-12	Identical

I.S. EN 1283:1996	HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS
BS EN 1782 : 1998	TRACHEAL TUBES AND CONNECTORS
BS EN 1282-1:1997	Anaesthetic and respiratory equipment. Tracheostomy tubes Tubes for use in adults
BS EN 600:1996	Natural rubber latex male condoms
BS ISO 7176-14:2008	Wheelchairs Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods
BS EN 12342 : 1998	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12342:1998-09	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12342:2010-01	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
EN 12181 : 1998	OROPHARYNGEAL AIRWAYS
EN 1283 : 1996	HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS
ISO 7176-14:2008	Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters Requirements and test methods
DIN EN 1782:2009-12	TRACHEAL TUBES AND CONNECTORS
BS 3704(1996) : 1996	NATURAL RUBBER LATEX MALE CONDOMS
I.S. EN 12181:1998	OROPHARYNGEAL AIRWAYS
UNE-EN 1782:1998	TRACHEAL TUBES AND CONNECTORS.
EN 1782:1998+A1:2009	Tracheal tubes and connectors
UNI EN 12342 : 2009	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
UNI EN 1782 : 2009	TRACHEAL TUBES AND CONNECTORS
I.S. EN 1819:1998	LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
MEDDEV 2.5-7 : REV 1 : 1998	GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES
ASTM F 1781 : 2015 : REDLINE	Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
BS EN 12181:1998	Oropharyngeal airways
BS EN 1615:2000	Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing
BS EN 1819:1998	Laryngoscopes for tracheal intubation. Particular requirements
EN 12342:1998+A1:2009	Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN 1819 : 1997	LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
EN 1282-1 : 1996	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - TUBES FOR USE IN ADULTS