DIN EN 12011:1998-03

Отменен

Instrumentation to be used in association with non-active surgical implants - General requirements; German version EN 12011:1998 — 12 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

DIN ISO 5832-2 Berichtigung 1:2008-06

Отменен

Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:1999), Corrigendum to DIN ISO 5832-2:2000-08 — 2 стр.

DIN ISO 5832-3:2000-08

Отменен

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996) — 4 стр.

DIN ISO 5832-4:2000-08

Отменен

Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy (ISO 5832-4:1996) — 3 стр.

DIN ISO 5832-5:2008-04

Действует

Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy (ISO 5832-5:2005) — 6 стр.

DIN ISO 5832-6:2001-04

Отменен

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997) — 4 стр.

DIN ISO 5832-7:2001-07

Отменен

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:1994) — 4 стр.

DIN ISO 5832-8:2000-08

Отменен

Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy (ISO 5832-8:1997) — 4 стр.

DIN EN 540 Berichtigung 1:1998-08

Отменен

Corrigenda to DIN EN 540:1993-07; Corrigendum EN 540/AC:1998-02 — 1 стр.

DIN EN 550:1994-11

Отменен

Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization; German version EN 550:1994 — 21 стр.

DIN EN 552:2001-02

Отменен

Sterilization of medical devices - Validation and routine control of sterilization by irradiation (includes Corrigendum 1:1999 (A1:1999) and Amendment A2:2000); German version EN 552:1994 + Corrigendum 1:1999 (A1:1999) + Amendment A2:2000 — 29 стр.

DIN EN 554:1994-11

Отменен

Sterilization of medical devices - Validation and routine control of sterilization by moist heat; German version EN 554:1994 — 14 стр.

DIN EN 556-1 Berichtigung 1:2006-12

Действует

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006 — 2 стр.

DIN EN 724:1994-12

Отменен

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices; German version EN 724:1994 — 18 стр.

DIN EN 868-10:2009-09

Отменен

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2009 — 17 стр.

DIN EN 980:2008-08

Отменен

Symbols for use in the labelling of medical devices; German version EN 980:2008 — 37 стр.

DIN EN 1041:2008-11

Отменен

Information supplied by the manufacturer of medical devices; German version EN 1041:2008 — 32 стр.

DIN EN 1174-1:1996-03

Отменен

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements; German version EN 1174-1:1996 — 8 стр.

DIN EN 14419:2009-07

Отменен

District heating pipes - Preinsulated bonded pipe systems for directly buried hot water networks - Surveillance systems; German and English version EN 14419:2009 — 51 стр.

DIN EN 30993-1:1994-12

Отменен

Biological evaluation of medical devices - Part 1: Guidance on selection of tests (ISO 10993-1:1992 + Technical Corrigendum 1:1992); German version EN 30993-1:1994 — 12 стр.

DIN EN 30993-3:1994-03

Отменен

Biological evaluation of medical devices; part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992); German version EN 30993-3:1993 — 8 стр.

DIN EN 30993-4:1994-06

Отменен

Biological evaluation of medical devices; part 4: selection of tests for interactions with blood (ISO 10993-4:1992); German version EN 30993-4:1993 — 17 стр.

DIN EN 30993-5:1994-08

Отменен

Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: In vitro-methods (ISO 10993-5:1992); German version EN 30993-5:1994 — 8 стр.

DIN EN 30993-6:1994-12

Отменен

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994); German version EN 30993-6:1994 — 10 стр.

DIN EN 46001:1996-09

Отменен

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001; German version EN 46001:1996

DIN EN 46002:1996-09

Отменен

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002; German version EN 46002:1996

DIN EN 60068-2-27:1995-03

Отменен

Basic environmental testing procedures - Part 2: Tests; test Ea and guidance: Shock (IEC 60068-2-27:1987); German version EN 60068-2-27:1993 — 24 стр.

DIN EN 60068-2-47:2006-03

Действует

Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests (IEC 60068-2-47:2005); German version EN 60068-2-47:2005 — 36 стр.

DIN EN ISO 10993-10:2009-08

Отменен

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009 — 68 стр.

DIN EN ISO 10993-11:2009-08

Отменен

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); German version EN ISO 10993-11:2009 — 36 стр.

DIN EN ISO 4957:2001-02

Отменен

Tool steels (ISO 4957:1999); German version EN ISO 4957:1999 — 31 стр.

DIN EN ISO 7153-1:2001-02

Отменен

Surgical instruments - Metallic materials - Part 1: Stainless steel (ISO 7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000 — 7 стр.

DIN EN ISO 16061:2010-01

Отменен

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009 — 27 стр.

На этот документ ссылаются

DIN EN ISO 7439:2011-09

Отменен

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011); German version EN ISO 7439:2011 — 22 стр.

DIN EN ISO 7439:2002-10

Отменен

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002); German version EN ISO 7439:2002 — 15 стр.

DIN EN ISO 7439:2010-12

Отменен

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002); German version EN ISO 7439:2009 — 20 стр.

DIN EN ISO 7439:2011-04

Отменен

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO/FDIS 7439:2011); German version FprEN ISO:2011 — 22 стр.

DIN EN ISO 7439:2015-08

Действует

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015); German version EN ISO 7439:2015 — 19 стр.

DIN EN ISO 7439:2010-10

Отменен

Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO/FDIS 7439:2010); German version FprEN ISO 7439:2010 — 20 стр.

DIN EN ISO 16061:2010-01

Отменен

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009 — 27 стр.