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DIN EN ISO 10993-7:2009-02

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Available format(s)

Hardcopy , PDF

Superseded date

29-08-2022

Published date

01-02-2009

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Anforderungen
  4.1 Allgemeines
  4.2 Einteilung der Produkte in Kategorien
  4.3 Zulässige Grenzwerte
  4.4 Bestimmung von Restgehalten an EO und ECH
5 Freigabe von Produkten
  5.1 Allgemeines
  5.2 Produktfreigabe ohne Dissipationskurvendaten
  5.3 Produktfreigabe unter Verwendung von
      Dissipationskurven der Rückstände
Anhang A (normativ) Auswertung von Gaschromatogrammen
Anhang B (informativ) Gaschromatographische Bestimmung
          von EO und ECH
Anhang C (informativ) Flussdiagramm und Anleitung für
          die Anwendung dieses Teils der
          ISO 10993-Normenreihe zur Bestimmung von EO-
          und ECH-Rückständen in Medizinprodukten
Anhang D (informativ) Faktoren, die den Restgehalt im
          Produkt beeinflussen
Anhang E (informativ) Extraktionsbedingungen für
          die Bestimmung von Rest-EO
Anhang F (informativ) Begründung für die Vorkehrungen
          in diesem Teil von ISO 10993
Anhang G (informativ) Festlegung der zulässigen
          Grenzwerte für EO
Anhang H (informativ) Festlegung der zulässigen
          Grenzwerte für ECH
Anhang I (informativ) Festlegung der zulässigen
          Grenzwerte für EG
Anhang J (informativ) Herstellung von EO- und
          ECH-Standards
Anhang K (informativ) Verfahren zur Messung von
          Ethylenoxidrückständen
Anhang ZA (informativ) Zusammenhang zwischen
          dieser Europäischen Norm und den
          grundlegenden Anforderungen der EG-Richtlinie
          93/42/EWG über Medizinprodukte
Anhang ZB (informativ) Zusammenhang zwischen
          dieser Europäischen Norm und den
          grundlegenden Anforderungen der EG-Richtlinie
          90/385/EWG über aktive implantierbare
          Medizinprodukte
Literaturhinweise
Bilder
Tabellen

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.

DocumentType
Standard
Pages
108
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
DIN EN ISO 8638:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
DIN EN ISO 7199:2015-06 (Draft) CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
DIN EN ISO 22803:2006-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
DIN EN ISO 10993-1:2010-04 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)
DIN EN ISO 8637:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01)
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
AAMI ST30 : 1989 DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES
AAMI ST29 : 1988 DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
AAMI ST43 : 3ED 93 GOOD HOSPITAL PRACTICE: ETHYLENE OXIDE GAS - VENTILATION RECOMMENDATIONS AND SAFE USE
DIN EN ISO 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN EN ISO 10993-10:2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
DIN EN ISO 10993-17:2009-08 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
DIN EN ISO 10993-3:2015-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)

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