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EFHSS - Questions & Answers - Miscellaneous - Q00551
EN 285

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From: (Turkey) Date: 27 July 2004, 08:42 [GMT]
Subject: EN 285

We have a pr EN 285 : 2002 Standard, Is This standard revised as EN 285 : 2002? Can you help to us?

And We are working for MDD (93/42/EEC) but is vessel of Steam Sterilizer marked before for PED (97/23/EEC). Is This condition true?

From: Miki Date: 30 July 2004, 14:47 [GMT]
Subject: Re: EN 285

EN 285:96 is the appropriate one. Where to you rush.

Both, the MEDICAL DEVICE and PRESSURE EQUIPMENT are regulated to comply with the Directives. The pressure equipment is part (or component) of the MD. You must have 2 NoBo:one for the MD and the other for PE. The pressure vessel will be marked in compliance with the PED, and the Name plate of the sterilizer will be marked in compliance with the MDD

miki

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