DIN EN ISO 10993-7:2009-02
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Hardcopy , PDF
01-02-2009
29-08-2022
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Superseded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 |
| Standards | Relationship |
| ISO 10993-7:2008 | Identical |
| NS EN ISO 10993-7 : 2008 AC 2009 | Identical |
| EN ISO 10993-7 : 2008 COR 2009 | Identical |
| NBN EN ISO 10993-7 : 2008 COR 2009 | Identical |
| BS EN ISO 10993-7:2008 | Identical |
| NF EN ISO 10993-7 : 2008 | Identical |
| NEN EN ISO 10993-7 : 2008 C1 2009 | Identical |
| I.S. EN ISO 10993-7:2008 | Identical |
| ONORM EN ISO 10993-7 : 2010 | Identical |
| UNE-EN ISO 10993-7:2009 | Identical |
| 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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