YY/T 0093-2013Medical diagnostic X-ray image intensifier (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

Instead of the standard YY/T 0093-2004 "Medical Diagnostic X-ray image intensifier," compared with the YY/T 0093-2004 main technical Surgery changes are as follows.

--- Reference document, with instead of GB 9706.1-2007 GB 9706.1-1995;

--- Reference document, with GB/T 9969-2008 instead of GB/T 9969.1-1998;

--- Reference file with YY/T 0291-2007 instead of YY/T 0291-1997;

--- Reference file with YY/T 1099-2007 instead of YY 91099-1999;

--- Deleted the reference document YY/T 91055-1999 "Medical Devices coat of paint category. technical conditions";

--- Delete references GB 9706.12-1997 "Medical electrical equipment Part 1. General requirements for safety juxtaposition.

Quasi diagnostic X-ray equipment General requirements for radiation protection "(idtIEC 60601-1-3.1994);

--- Delete references GB/T 2828.1-2003 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) inspection CABLE batch inspection sampling plan (ISO 2859-1:1999, IDT);

--- Delete references GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test);

--- Added 33cm image intensifier requirements;

--- Temperature conditions climatic environmental tests have been adjusted;

--- Define the scope of products.

1 Scope

This standard specifies the diagnostic X-ray image intensifier (hereinafter referred to as booster) requirements, test methods, inspection rules, marking, Manual, packaging, transportation and storage.

This standard applies to nominal incident horizons of 15cm (6in), 23cm (9in), 30cm (12in), 33cm (13in) and 40cm (16in) equipped with X-ray image reduction Enhanced image intensifier tubes, including single vision and multi-vision. These products are mainly used with Supporting medical diagnostic X-ray equipment used for image conversion.

This standard does not apply to flat-type or other type of booster.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety

GB/T 9969-2008 General Industrial Product Manual

YY 0076-1992 metal parts coating technology classification conditions

YY/T 0291-2007 medical X-ray equipment environmental requirements and test methods

YY/T 0457.1-2003 Medical electrical equipment - optical X-ray image intensifiers - Part 1.

YY/T 0457.3-2003 Medical electrical equipment - optical X-ray image intensifiers - Part 3.

YY/T 0457.6-2003 Medical electrical equipment - optical X-ray image intensifiers - Part 6. Department of contrast and glare Determination of the number of YY/T 1099-2007 medical X-ray equipment packaging, transport and storage

3 Terms and Definitions

YY/T 0457 defined by the following terms and definitions apply to this document.