EN 60601-2-8:1997/A1:1997

Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

EN following parallel vote

Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Therapie-Röntgeneinrichtungen im Betriebsbereich von 10 kV bis 1 MV

Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour les équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV

Medicinska električna oprema - 2. del: Posebne varnostne zahteve za terapevtsko rentgensko opremo, ki deluje v območju od 10 kV do 1 MV - Dopolnilo A1 (IEC 60601-2-8:1987/A1:1997)

General Information

• Status: Withdrawn
• Publication Date: 08-Sep-1997
• Withdrawal Date: 31-May-1998
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 14-Apr-2018
• Completion Date: 14-Apr-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-8:1998/A1:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV - Amendment A1 (IEC 60601-2-8:1987/A1:1997)

Relations

• Replaced By: EN 60601-2-8:2015 - Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 28-Jan-2023
• Amends: EN 60601-2-8:1997 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-8:1998/A1:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DWHUDSHYWVNR
UHQWJHQVNRRSUHPRNLGHOXMHYREPRþMXRGN9GR09'RSROQLOR$,(&
$
Medical electrical equipment - Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating in the range 10 kV to 1 MV - Amendment A1 (IEC
60601-2-8:1987/A1:1997)
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
Therapie-Röntgeneinrichtungen im Betriebsbereich von 10 kV bis 1 MV (IEC 60601-2-
8:1987/A1:1997)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour les
équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV
(CEI 60601-2-8:1987/A1:1997)
Ta slovenski standard je istoveten z: EN 60601-2-8:1997/A1:1997
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-8:1998/A1:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-8:1998/A1:1998

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SIST EN 60601-2-8:1998/A1:1998

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SIST EN 60601-2-8:1998/A1:1998

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SIST EN 60601-2-8:1998/A1:1998

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SIST EN 60601-2-8:1998/A1:1998

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SIST EN 60601-2-8:1998/A1:1998
NORME
CEI
INTERNATIONALE
IEC
60601-2-8
INTERNATIONAL
1987
STANDARD
AMENDEMENT 1
AMENDMENT 1
1997-08
Amendement 1
Appareils électromédicaux –
Partie 2:
Règles particulières de sécurité pour
les équipements à rayonnement X de thérapie
fonctionnant dans la gamme de 10 kV à 1 MV
Amendment 1
Medical electrical equipment –
Part 2:
Particular requirements for the safety of
therapeutic X-ray equipment operating in
the range 10 kV to 1 MV
 IEC 1997 Droits de reproduction réservés  Copyright - all rights reserved
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE S
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-8:1998/A1:1998
60601-2-8 Amend. 1 © IEC:1997 – 3 –
FOREWORD
This amendment has been prepared by subcommittee 62C: Equipment for radiotherapy,
nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment
in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62C/186/FDIS 62C/193/RVD
Full information on the voting for the approval of this amendment can be found in the report on
voting indicated in the above table.
––––––––
Page 3
CONTENTS
Add, after PREFACE, the following title:
INTRODUCTION
Add the titles of the following new subclauses:
1.3.103 IEC 61217
1.5 Collateral Standards
6.3 Marking of controls and instruments
Replace the title of SECTION TWO by the following:
SECTION TWO – ENVIRONMENTAL CONDITIONS
Replace the title of clause 18 by the following:
18 Protective earthing, functional earthing and potential equalization
Page 5
Add the titles of the following new subclauses:
29.103 Indication of X-RADIATION output
29.104 Agreement between indicated values and effective values
29.105 General test conditions
29.106 Settings for measurements
29.107 Number of measurements
29.108 Measurements and evaluation

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SIST EN 60601-2-8:1998/A1:1998
60601-2-8 Amend. 1 © IEC:1997 – 5 –
Replace the title of SECTION SIX by the following:
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
Replace the title of SECTION SEVEN by the following:
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
Delete the title of clause 48 and replace it by “Biocompatibility”.

Replace the title of SECTION EIGHT by the following:
SECTION EIGHT – ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
Delete the titles of subclauses 50.1 to 50.104.
Page 7
Delete the title of clause 59.4.
Replace “APPENDIX AA” by “ANNEX AA”.
Add, after ANNEX AA, the following new ANNEX BB:
ANNEX BB – List of standards mentioned in this Particular Standard
Page 9
FOREWORD
Replace the title by the following:
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating
in the range 10 kV to 1 MV

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SIST EN 60601-2-8:1998/A1:1998
60601-2-8 Amend. 1 © IEC:1997 – 7 –
Page 9
Replace the foreword and the preface
...