EN 46001 : 1996
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
Superseded date
10-25-2000
Superseded by
Published date
01-12-2013
Publisher
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Foreword
0 Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Design control
4.5 Document and data control
4.6 Purchasing
4.7 Control of customer-supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.11 Control of inspection, measuring and test equipment
4.12 Inspection and test status
4.13 Control of nonconforming product
4.14 Corrective and preventive action
4.15 Handling, storage, packaging, preservation and delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
Annex A (informative) - Bibliography
Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.
| Committee |
TC 205, TC 62 & ýTC 140
|
| DevelopmentNote |
To be read in conjunction with EN ISO 9001. (07/2003) Supersedes ENV 50076. (08/2005)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| CEI EN 46001 : 2ED 1996 | Identical |
| NBN EN 46001 : 1996 | Identical |
| NEN EN 46001 : 1996 | Identical |
| UNI CEI EN 46001 : 1996 | Identical |
| BS EN 46001:1997 | Identical |
| I.S. EN 46001:1997 | Identical |
| SN EN 46001 : 1997 | Identical |
| NF EN 46001 : 1996 | Identical |
| DIN EN 46001:1996-09 | Identical |
| UNE-EN 46001:1996 | Identical |
| I.S. EN 1283:1996 | HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS |
| I.S. EN 12022:1999 | BLOOD GAS EXCHANGERS |
| CR 14060:2000 | Medical device traceability |
| BS EN 13795-1 : 2002 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| DIN EN 737-3:1998-11 | MEDICAL GAS PIPELINE SYSTEMS - PART 3: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| EN 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| EN 12022:1999 | Blood gas exchangers |
| CR 12401 : 1996 | DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
| EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| EN 12442-2 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
| I.S. EN 12442-3:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| 99/124125 DC : DRAFT NOV 1999 | BS EN ISO 15883-1 - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, DEFINITIONS AND TESTS |
| CEI UNI EN 46003 : 2001 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003 |
| DIN EN 737-3:2000-01 | MEDICAL GAS PIPELINE SYSTEMS - PART 3: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| I.S. EN 12442-2:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
| I.S. EN 737-3:1999 | MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| 03/317861 DC : DRAFT OCT 2003 | EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| CSA Z7396.2 : 2002 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS |
| BS EN 12022:1999 | Blood-gas exchangers |
| BS EN 12442-2:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling |
| EN 724 : 1994 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES |
| EN 13795-1:2002+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products |
| UNI EN 13795-1 : 2009 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| CEI EN 50103 : 1996 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY |
| BS EN 46003:1999 | Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003 |
| BS EN 13612:2002 | Performance evaluation of in vitro diagnostic medical devices |
| BS EN 556:1995 | Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\' |
| BS EN 737-3:2000 | Medical gas pipeline systems Pipelines for compressed medical gases and vacuum |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| BS EN 12442-3:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents |
| BS EN 12523:1999 | External limb prostheses and external orthoses. Requirements and test methods |
| I.S. EN 13795-1:2002 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| EN 928 : 1995 | IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 737-2:1998/A1:1999 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
| EN 737-3:1998/A1:1999 | MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| I.S. EN 737-2:1998 | MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
| 02/121895 DC : DRAFT APR 2002 | BS EN 13060 - SMALL STEAM STERILIZERS |
| S.R. CR 14060:2000 | MEDICAL DEVICE TRACEABILITY |
| PD CR 12401:2003 | Dentistry. Guidance on the classification of dental devices and accessories |
| AAMI QSR : 1996 | QUALITY SYSTEM REGULATION (21 CFR PARTS 808, 812 AND 820) - OCTOBER 1996 |
| BS EN 12322:1999 | In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media |
| BS EN 868-1:1997 | Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods |
| EN 12523 : 1999 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| DIN EN 13795-1:2009-10 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| EN 1174-1 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS |
| BS EN ISO 9001:2015 | Quality management systems. Requirements |
| EN 724 : 1994 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| EN 50103 : 1995 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY |
| EN 928 : 1995 | IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES |
| EN ISO 8402 : 1995 | QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY |
| BS EN ISO 8402:1995 | Quality management and quality assurance. Vocabulary |
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