Standard Svensk standard · SS-EN 60601-2-17

Elektrisk utrustning för medicinskt bruk - Säkerhet - Del 2-17: Särskilda fordringar på automatiska efterladdningsutrustningar för brachyterapi

Status: Upphävd

· Ersätts av: SS-EN 60601-2-17
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Standard Svensk standard · SS-EN 60601-2-17

Elektrisk utrustning för medicinskt bruk - Säkerhet - Del 2-17: Särskilda fordringar på automatiska efterladdningsutrustningar för brachyterapi
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Omfattning
1.1.101 This Particular Standard specifies requirements for the safety of automatically-
controlled EQUIPMENT for BRACHYTHERAPY of patients using AFTERLOADING techniques.
1.1.102 This Standard specifies requirements for automatically-controlled AFTERLOADING EQUIPMENT
– which contains and uses only beta, gamma, and NEUTRON-emitting SEALED RADIOACTIVE SOURCES,
– which automatically drives the sealed radioactive source(s) from a storage container to a treatment position inside the source applicator(s) and returns the source(s) to the storage container,
– which is designed for connection to a PATIENT, and
– with which movements of the RADIOACTIVE SOURCE(S) are carried out automatically by the EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems.
1.1.103 This Standard specifies requirements for EQUIPMENT intended to be
– used under the supervision of QUALIFIED PERSONS;
– maintained at predetermined intervals;
– subject to regular checks by the user.
This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES used with the EQUIPMENT. Such requirements are specified in other standards (see 6.8.3).
1.1.104 The requirements of this Standard are based on the assumptions that:
– a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT PARAMETERS, and
– the SOURCE STRENGTH(S) of the RADIOACTIVE SOURCE(S) used by the EQUIPMENT is (are) known.

Ämnesområden

Terapiutrustning (11.040.60) Oförstörande provning (19.100)


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Standard Svensk standard · SS-EN 60601-2-17

Elektrisk utrustning för medicinskt bruk - Säkerhet - Del 2-17: Särskilda fordringar på automatiska efterladdningsutrustningar för brachyterapi
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Produktinformation

Språk: Engelska

Framtagen av: SEK SVENSK ELSTANDARD

Internationell titel: Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

Artikelnummer: STD-3331766

Utgåva: 2

Fastställd: 2004-10-25

Antal sidor: 32

Ersätter: SS-EN 60601-2-17 , SS-EN 60601-2-17 A 1

Ersätts av: SS-EN 60601-2-17