iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CLC

EN 60601-2-29:1995/A1:1996

(Amendment)

Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators

Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators

EN following parallel vote * Superseded by EN 60601-2-29:1999

Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von Strahlentherapiesimulatoren

Appareils électromédicaux - Partie 2: Règles particulières de sécurité des simulateurs de radiothérapie

Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators - Amendment A1 (IEC 60601-2-29:1993/A1:1996)

General Information

Status
Withdrawn
Publication Date
11-Dec-1996
Withdrawal Date
12-Jun-1998
ICS
11.040.60 - Therapy 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
01-Apr-2002
Completion Date
01-Apr-2002
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
SIST EN 60601-2-29:1998/A1:1998 - Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators

Relations

Replaced By
EN 60601-2-29:1999 - Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators
Effective Date
29-Jan-2023
Amends
EN 60601-2-29:1995 - Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators
Effective Date
29-Jan-2023

Buy Standard

EN 60601-2-29:1998/A1:1998EN 60601-2-29:1998/A1:1998
PreviousNext
Amendment
EN 60601-2-29:1998/A1:1998
English language
9 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI STANDARD
01-september-1998
Medical electrical equipment - Part 2: Particular requirements for the safety of
radiotherapy simulators - Amendment A1 (IEC 60601-2-29:1993/A1:1996)
Medical electrical equipment -- Part 2: Particular requirements for the safety of
radiotherapy simulators
Medizinische elektrische Geräte -- Teil 2: Besondere Festlegungen für die Sicherheit von
Strahlentherapiesimulatoren
Appareils électromédicaux -- Partie 2: Règles particulières de sécurité des simulateurs
de radiothérapie
Ta slovenski standard je istoveten z: EN 60601-2-29:1995/A1:1996
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN 60601-2-29:1998/
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CLC
EN 60601-2-6:2015/A2:2024(Amendment)
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
SIST EN 60601-2-6:2015/A2:2024
  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-2-10:2015/A2:2024(Amendment)
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
SIST EN 60601-2-10:2015/A2:2024
  • Amendment
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-2-3:2015/A2:2024(Amendment)
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
SIST EN 60601-2-3:2015/A2:2024
  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-50:2021/A1:2023(Amendment)
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
SIST EN IEC 60601-2-50:2021/A1:2024
  • Amendment
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-1:2021(Main)
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
SIST EN IEC 60601-2-1:2021

IEC 60601-2-1:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS. NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery – intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having • NOMINAL ENERGY in the range 1 MeV to 50 MeV, • maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and • REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE; and – intended to be • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and • subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON. IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with the new relevant collateral standards; b) addition of computer interface and control; c) addition of new technologies in RADIOTHERAPY, including • BEAM GATING, and • ADAPTIVE RADIOTHERAPY.

  • Standard
    118 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-50:2021(Main)
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
SIST EN IEC 60601-2-50:2021

IEC 60601-2-50:2020 is available as IEC 60601-2-50:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-50:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-50:2020 specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. IEC 60601-2-50:2020 does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21. IEC 60601-2-50:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-50:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

  • Standard
    33 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-83:2020/A11:2021(Amendment)
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
SIST EN IEC 60601-2-83:2020/A11:2021

2021-02.09 -JO - positive assessment for MDD (EN IEC 60601-2-83:2020 - PR= 64477) and the comments of the HAS consultant for MDR was resolved by the TC for EN IEC 60601-2-83:2020/prA11 - PR= 72969
This A11 introduces a revised Annex ZA & Annex ZZ  to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR (2017/745)

  • Amendment
    10 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-83:2020(Main)
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
SIST EN IEC 60601-2-83:2020

IEC 60601-2-83:2019 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR. The scope of this document includes all light sources except laser.

  • Standard
    34 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 62667:2018(Main)
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
SIST EN IEC 62667:2018

IEC 62667:2017 applies to light ion beam ME equipment when used, for therapy purposes, in human medical practice. This document applies to light ion beam ME equipment which delivers light ion beams with an energy per nucleon in the range 10 MeV/n to 500 MeV/n. This document describes measurements and test procedures to be performed by the manufacturer of light ion beam ME equipment but does not specify acceptance tests. This document specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is necessary for proper selection, application, and use of light ion beam ME equipment and which are to be declared in the accompanying documentation together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of performance values is given in Annex A.

  • Standard
    121 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-2-10:2015/A1:2016(Amendment)
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
SIST EN 60601-2-10:2015/A1:2017
  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day