SIST EN 285:2006

Oznaka standarda: SIST EN 285:2006
Koda projekta: 00102048
Organizacija: SIST
Naslov (angleški): Sterilization - Steam sterilizers - Large sterilizers
Naslov (slovenski): Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji
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Ime Jezik Status Cena Dodaj v košarico
SIST EN 285:2006 angleški jezik Withdrawn SIST-M: 119.79 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.080.10
Status: Razveljavljen
Objavljen: 01-jul-2006
Refer. št. objave: Sporocila 2006-07-01
Razveljavitev: 01-jul-2008
Referenca razveljavitve: Sporočila 2008-07
Referenčna oznaka: EN 285:2006
Področje projekta (angleško): 1.1 This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. Large steam sterilizers can also be used during the commercial production of medical devices. 1.2 This European Standard is not applicable to steam sterilizers designed to process a size of load less than one sterilization module or having a chamber volume less than 60 l. 1.3 This European Standard does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer. NOTE Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. 1.4 Planning and design of products applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A. NOTE Additional aspects of environmental impact are addressed in EN ISO 14971.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN 285:2000/AC:2000 - Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji 01-jul-2006
Nadomešča SIST EN 285:2000 - Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji 01-jul-2006
Dopolnjen z SIST EN 285:2006/oprA1:2006 - Sterilizacija – Parni sterilizatorji – Veliki sterilizatorji 22-dec-2008
Konsolidiran z SIST EN 285:2006+A1:2008 - Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji 01-jul-2008
Konsolidiran z SIST EN 285:2006+A2:2009 - Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji 01-jul-2009
Dopolnjen z SIST EN 285:2006/kprA2:2009 - Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji 01-mar-2009


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