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About This Item

 

Full Description

1. Scope and Object

This clause of part 1 is applicable except as follows:

1.1 Scope

Replacement:

This standard applies to AUTOCLAVES, including those with an automatic loading and unloading system, which incorporate a PRESSURE VESSEL using steam within the absolute pressure range from 0 to 500 kPa, and intended for the treatment of medical materials and for laboratory processes, for example for sterilization.

NOTES (1) National and other regulations or codes apply for the safety of automatic loading and unloading systems. (2) All pressures are specified in absolute terms. Atmospheric pressure (1 bar) = 100 kPa.

Where an AUTOCLAVE incorporates a steam generator having its own PRESSURE VESSEL within the same enclosure, the applicable safety requirements for the AUTOCLAVE PRESSURE VESSEL apply also to the steam generator (see 14.105).

1.1.2

Equipment excluded from the scope

Addition:

Add the following new dash:

- pressurized environmental cabinets.

NOTES (1) Since all AUTOCLAVES covered by this part 2 use steam, other types using dry heat, toxic gas or radiation are not included. (2) This standard does not deal with special requirements for protection against chemical and high-risk micro-biological hazards associated with the AUTOCLAVE LOAD, nor with requirements for the design of the PRESSURE VESSEL itself.

1.4

Environmental conditions

Replacements:

Replace the first dash by the following new dash: - indoor use, and outdoor use for AUTOCLAVES if specified by the m anufacturer (see 11.6 of part 1).

Replace the fourth dash by the following new dash: - maximum relative humidity 85% at any temperature between 5?C and 40?C. /

1. Domaine d'application et objet

Cet article de la partie 1 est applicable, a l'exception de ce qui suit:

1.1 Domaine d'application

Remplacement:

Cette norme s'applique aux AUTOCLAVES y compris ceux ayant un systeme automatique de chargement et dechargement, qui comportent un RECIPIENT SOUS PRESSION utilisant de la vapeur a l 'interieur de la plage de pressions absolues de 0 kPa a 500 kPa, et prevus pour le traitement des materiaux a usage medical et dans les procedes de laboratoire, par exemple pour la sterilisation.

NOTES (1) Les obligations ou regles legales nationales ou autres s'appliquent pour la securite des systemes automatiques de chargement et de dechargement. (2) La pression atmospherique (1 bar) est = 100 kPa.

Dans le cas ou un AUTOCLAVE comporte un generateur de vapeur ayant dans la meme enveloppe son propre RECIPIENT SOUS PRESSION, les pre scriptions de securite applicables au RECIPIENT SOUS PRESSION de l'AUTOCLAVE s'appliquent aussi au generateur de vapeur (voir 14.105).

1.1.2

Appareils exclus du domaine d'application

Addition:

Ajouter le nouveau tiret suivant:

- enceinte d'environnement sous pression.

NOTES (1) Du fait que tous les AUTOCLAVES concernes par cette partie 2 font usage de vapeur, les autres types utilisant de la chaleur seche, des gaz toxiques ou des radiations ne sont pas concernes. (2) Cette norme ne precise pas non plus les prescriptions speciales pour la protection contre les dangers des produits chimiques et microbiologiques a haut risque associes a la CHARGE de l'AUTOCLAVE, ni les prescriptions concernant la conception du RECIPIENT SOUS PRESSION lui-meme.

1.4

Conditions d'environnement

Remplacements:

Remplacer le premier tiret par le nouveau tiret qui suit: - utilisation a l'interieur et a l'exterieur si specifie par le constructeur (voir 11.6 de la partie 1).

Remplacer le quatrieme tiret par le nouveau tiret qui suit: - humidite relative maximale 85% pour toutes les temperatures compri ses entre 5?C et 40?C.