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Owing to the directive 93/42/EEC on medical devices and the harmonised medical
device act (MDA), standards have become more and more important. They define the
minimum level of technology to be observed by the manufacturer when planning,
manufacturing, operating and applying medical
devices.
Sterilizers are medical products of class IIa (according to article 10,
appendix IX in 93/42 EEC) that serve the sterilization of medical devices in the
health care sector. The operator, too, must know what the standards say.
According to §6 of the operator’s directive relating to MDA, the “generally
accepted rules of technology” are to be observed during safety controls.
We have listed below the standards relevant to the following topics:
The listing gives an overview of all important standards relevant in the field of sterilization in the health care
sector. The abbreviations mean:
| DIN |
Deutsche Industrie Norm (German industrial standard) |
|
E DIN |
published draft of a German standard |
|
EN |
European standard |
|
DIN EN |
harmonisierte (europäische) Norm |
|
prEN E DIN EN |
published draft of a European standard |
|
E DIN EN ISO |
published draft of a German, European, international standard |
|
prEN ISO
|
published draft of a European, international standard |
| Manuskript |
planning stage |
| pr EN ISO 15883-1 |
Washer-disinfectors |
| DIN 58949 |
Dampf-Desinfektionsapparate |
| (1/01) Teil 1 |
Begriffe |
| (1/01) Teil 2 |
Anforderungen |
| (5/91) Teil 3 |
Prüfung auf Wirksamkeit (wird zur Zeit überarbeitet) |
| (5/91) Teil 4 |
Bio-Indikatoren zur Prüfung auf Wirksamkeit (wird z.Z.
überarb.) |
| (9/92) Teil 6 |
Betrieb von Dampf-Desinfektionsapparaten (wird z.Z.
überarb.) |
| (1/01) Teil 7 |
Bauliche Anforderungen und Anforderungen an die
Betriebsmittel |
| DIN 58955 |
Dekontaminationsanlagen im Bereich Medizin |
| (9/92) Teil 1 |
Begriffe |
| (9/98) Teil 2 |
Anforderungen |
| (9/98) Teil 3 |
Prüfung auf Wirksamkeit |
| (9/98) Teil 4 |
Biologische Indikatoren - Anforderungen |
| (3/01) Teil 6 |
Betrieb |
| (3/01) Teil 7 |
Bauliche Anforderungen und Anforderungen an die
Betriebsmittelversorgung |
|
DIN EN 556 |
Sterilization of medical devices |
|
(1/95) |
requirements for products labelled “sterile”. Includes the definition of “sterile”. |
|
DIN EN 1174
|
Sterilization of medical devices - estimation of the population of micro-organisms on product |
| (3/96) Teil 1 |
Requirements |
| (2/97) Teil 2 |
Handbook |
|
(2/97) Teil 3
|
Handbook on validation procedures of microbiological methods |
| (prEN) Teil 4
|
Handbook on the estimation and interpretation of bioburden values |
|
prEN ISO 14937
|
General requirements for characterization of a sterilizing agent and the
development, validation and routine control of a sterilization process for medical devices |
|
DIN EN 550 |
Sterilization of medical products Requirements for the validation |
|
(11/94) |
and routine control - ethylene oxide sterilization |
|
DIN EN 552 |
Sterilization of medical products
Requirements for the validation and |
|
(11/94) |
routine control - radiation sterilization |
|
DIN EN 554 |
Sterilization of medical products
Requirements for the validation and |
|
(11/94) |
routine control - moist heat sterilization |
|
Commissioning, performance qualification, conduct of validation of steam sterilizers |
|
DIN EN 866
|
Biological systems for testing sterilizers and sterilization processes |
| (5/97) Teil 1 |
Requirements |
|
(5/97) Teil 2 |
Systems for ethylene oxide sterilization |
|
(5/97) Teil 3 |
Systems for moist heat sterilization |
|
(2/99) Teil 4 |
Systems for radiation sterilization |
|
(2/99) Teil 5
|
Systems for low-temperature -steam and formaldehyde sterilization |
|
(2/99) Teil 6 |
Systems for dry heat sterilization |
|
(2/99) Teil 7 |
Biological indicators for steam sterilization |
|
(2/99) Teil 8
|
Biological indicators for ethylene oxide
sterilization |
Note: part 4 to 8 are in the planning stage (E DIN EN)
|
DIN EN 867 |
Non-biological systems for sterilizers |
|
(5/97) Teil 1 |
General requirements |
| (5/97) Teil 2 |
Process indicators |
| (5/97) Teil 3 |
Details on indicators class B for Bowie-Dick test |
|
(7/99) Teil 4
|
Determination of indicators that can be used instead of the Bowie-Dick test to prove steam penetration |
| (2/98) Teil 5
|
Determination of indicator systems and test samples for performance qualification of small sterilizers of type B and type S |
| DIN EN 285 |
Large steam sterilizers |
|
(2/97) |
Requirements and test procedures |
|
Applies to all steam sterilizers of a capacity of one sterilization unit
(StE) or more. |
|
DIN 58946 |
Steam sterilizers |
| (6/00) Teil 6 |
Operation of large sterilizers in the health care sector |
|
(6/00) Teil 7 |
Draft 2000 constructional requirements for steam sterilizers |
|
E DIN EN 13060
|
Small steam sterilizers, revised version 2000 supersedes DIN 58946, part 5 and 8 |
|
DIN 58950 |
Steam sterilizers for pharmaceutical goods to be sterilized |
|
(8/95) Teil 1 |
Terms |
|
(5/96) Teil 2 |
Requirements (1. manuscript 8/2000) |
|
(5/96) Teil 3 |
Acceptance testing |
|
(11/92) Teil 6 |
Operation |
|
(11/92) Teil 7 |
Services and constructional requirements |
|
E DIN 58951 |
Steam sterilizers for laboratory application |
|
DIN EN 1422 |
Sterilization for medical application - ethylene oxide- |
| (11/97) |
sterilization requirements and test procedures |
|
DIN 58948 |
Formaldehyde sterilization |
|
Teil 1 |
Terms (under revision) |
|
Teil 7
|
Constructional requirements and services for large ethylene
oxide and formaldehyde sterilizers (will be separated, formaldehyde sterilizers will form part 17) |
|
Teil 12
|
Large formaldehyde sterilizers, requirements (under
revision) |
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Teil 13
|
Efficiency test of formaldehyde sterilizers (part 13 together with
part 15 will be superseded by a DIN EN standard that is currently prepared by CEN/TC 102 WG 6) |
|
Teil 14
|
Bio-indicators for efficiency testing of formaldehyde gas sterilizers
(currently under revision) |
|
Teil 15
|
Small formaldehyde sterilizers, machine requirements,
services,
constructional requirements (part 15 together with part 13 will be uperseded by a DIN EN
standard that is currently prepared by CEN/TC 102 WG 6) |
|
Teil 16
|
Operation of formaldehyde gas sterilizers (under revision) |
|
Teil 18
|
Bio-indicators for efficiency testing of formaldehyde gas sterilizers used in industry |
|
Teil 19
|
Efficiency testing of formaldehyde gas sterilizers used in
industry. |
|
Currently H2O2 sterilization is not subject to any particular standard. However, a directive by the DGKH on validation is
being prepared. This is based on DIN EN ISO 14937. |
|
DIN 58947 |
Dry heat sterilizers |
|
Teil 1 |
Terms |
|
Teil 3 |
Efficiency testing |
|
Teil 4 |
Bio-indicators for efficiency testing |
|
Teil 5 |
Small sterilizers, requirements |
|
Teil 6 |
Operation of dry heat sterilizers |
DIN EN 868
(5/97)
|
Packaging material and systems for medical devices to be sterilized |
|
E DIN 58953 |
Sterile supply |
|
Teil 7
|
How to use paper pouches and heat sealing and self-adhesive
pouches and hoses made of paper and laminated foil |
|
Teil 8
|
Delivery, storage and handling of sterile consumables at the user |
|
Teil 9 |
Handling techniques of sterile containers |
|
Teil 10
|
Handling techniques of smooth and crinkled sterilization
paper. |
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