What is BS EN 61010-2-101 - Safety requirements for in vitro diagnostic (IVD) medical equipment about?
BS EN 61010-2-101 is the 101st subpart of the second part of multi-series standard that is applicable to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
BS EN 61010-2-101 helps you to improve the safety of in vitro diagnostic (IVD) medical equipment.
Who is BS EN 61010-2-101 - Safety requirements for vitro diagnostic (IVD) medical equipment for?
BS EN 61010-2-101 on vitro diagnostic (IVD) medical equipment is useful for:
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Manufacturers of In vitro diagnostic medical devices
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In vitro diagnostic clinics
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Regulatory authorities
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Clinical research organizations
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Investigators
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Assist sponsors
Why should you use BS EN 61010-2-101 - Safety requirements for in vitro diagnostic (IVD) medical equipment?
Self-test IVD medical equipment is intended by the manufacturer for use by laypersons in a home environment.
The purpose of BS EN 61010-2-101 is to provide information concerning one or more of the following:
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A physiological or pathological state
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A congenital abnormality
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The determination of safety and compatibility with potential recipients
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The monitoring of therapeutic measures
BS EN 61010-2-101 provides IVD medical equipment, whether used alone or in combination, this will help you with vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally.
What’s changed since the last update?
BS EN 61010-2-101:2017 supersedes BS EN 61010-2-101:2002 which is withdrawn.
BS EN 61010-2-101:2017 replaces the BS EN 61010-2-101:2002 published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes:
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Excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment
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Updated Biohazard and Lot symbols in Table 1 in Clause 5
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Added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5
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Added requirement for gas or liquid markings and ratings to Clause 5
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Added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5
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Added requirement for the manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5
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Added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5
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Added requirement for OPERATOR maintenance instructions to Clause 7
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Added requirements for sample zones and loading zones to Clause 7
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Excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8
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Added requirement for biohazard marking to Clause 13
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Added requirement for interlock systems containing electric/electronic or programmable components to Clause 15
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Added informative reference to Usability standard IEC 62366 to Clause 16
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Replaced Clause 17 with requirements of ISO 14971 for RISK assessment
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Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference is given to ISO 18113-5 in Clause 5