1、ENELEC Rue Brdsrade 2. Bte 5 O00 BFUXELLES TBI. ! (+ 3a.21 SI 9 68 71 - TGiex : 26257 Cenlac b FOX. I+3a 21519 SB 19 - Telece. %Cl6 ri?lT)(337 2ENCEL INFORMATION SHEET Issue 1 1989-09-01 HO 395.2.12 Sl Hedical electrical equipment Part 2: Particular requirements for the safety of lung ventilators f
2、or medical use Appareils electromdicaux Medizinische elektrische Gerate Deuxime partie: Teil 2: Rgles particulieres de scurit pour ventilateurs pulmonaires Sicherheit von Lungen-eatmungsgeraten usage mdical fr medizinische Anwendung Besondere Festlegungen fr die RD: IEC 601-2-12 (1988) ed 1; IEC/SC
3、620 (not appended) This Harmonization Document consists of the following: - Title Page Related to Directive: - date of ratification : 1988-12-06 date of announcement : 1989-07-01 date of latest publication : 1990-01-01 date of withdrawal : 1992-01-01 LIST OF NATIONAL STANDARDS IS GIVEN OVERLEAF _-_
4、m 3Li04583 00053A4 O W _ - .- - - HARMONIZED NATIONAL STANDARDS HO 395.2.12 S1 AT : BE : CH : DE : OK : NR (SR 135-2-12) ES : FI : FR : GE : GR : I : IS : IT : LU : NOS NL : NO : PT : SE : m 3qOq583 0005385 2 m RualErddemde 2, Bee 5 lo00 BFiUXELLEC TBI.:1+32.52519 68 71 - Twex: 2d3S7 Canlac b Fax. 1
5、i13a.2)519 68 19. Taiete.- 206 L21300) 2ENCEL CE N E LE C August 1989 HD 395.2.12 S1 I UDC: 615.84:615.816:616.24:614.8 KEY WORDS: Medical electrical equipment; lung ventilators; definitions; safety: particular requirements: protection against electric shock; fire prevention; tests; test conditions
6、MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS FOR MEDICAL USE Appareils electromdicdux Medizinische elektrische Gerate Deuxime partie: Teil 2: Rgles particulires de scurit pour ventilateurs pulmonaires usage mhdical fr medizinische Anwendung Besonder
7、e Festlegungen fr die Sicherheit von Lungen-Beatmungsgeraten BODY OF THE HD The Harmonization Document consists of: - - IEC 601-2-12 (1988) ed 1: IEC/SC 620, not appended This Harmonization Document was approved by CENELEC on 6 December 1988. The English and French versions of this Harmonization Doc
8、ument are provided by the text of the IEC publication and the German version is the official translation of the IEC text. According to the CENELEC Internal Regulations the CENELEC member National Committees are bound: to announce the existence of this Harmonization Document at national level by or b
9、efore 1989-07-01 to publish their new harmonized national standard by or before 1990-01-01 to withdraw all conflicting national standards by or before 1992-01-01. Harmonized national standards are listed on the HD information sheet, which is available from the CENELEC National Committees or from the
10、 CENELEC Central Secretariat. The CENELEC National Committees are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Copyright reserved to all CENELEC members
