YY 0669-2008Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment (English PDF)

1.1 Scope

Addition.

Specific requirements of this standard apply to defined 2.1.101 infant phototherapy device, this device is not to reduce the use of visible radiation Full month jaundice patient bilirubin.

1.2 Purpose

replace.

The specific standard is intended to determine as far as possible to reduce the infant phototherapy device to the patient and operator safety hazard requirements and regulations These requirements validation required for compliance testing.

1.3 Specific Standard

Addition.

The specific reference standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety." For simplicity, this special standard GB 9706.1 referred to as "General Standard" or general requirements.

The specific standard of articles, chapters of the number corresponding to a "common standard." Change the text of "universal standards" by using the following words Language to specify. "Replace" means the General Standard chapter or article dedicated completely replaced by the standard text. "Supplement" means this specific standard text is complementary to the universal standard. "Edit" means the General Standard article under this chapter or dedicated standard text to be modified.

Appended to the "General Standard" in Article 101 or FIG starting numbers attached appendix AA, BB, etc. No, but with additional entries aa), bb) and other numbers.

The term "this standard" is used as a "common standard" and this specific standard collectively.

There is no corresponding article, chapter or article in this specific standard, although may not be relevant, but the "General Standard" in the article, chapter or article should be no change to use. On the "General Standard" we do not intend to use any part of, although it may be relevant, but it should make a statement in this specific standard.

1.5 Collateral Standard

Addition.

GB 9706.15-1999 Medical electrical equipment - Part 1. General requirements for safety 1. Collateral standard.

YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests

GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety. Collateral Standard.

IEC 60601-1-4:2000 Medical electrical equipment - Part 1-4. General requirements for safety Collateral Standard. Programmable Electrical Medical system