British Standards Institution

Source:: ISO
Committee:: CH/212 - IVDs
Categories:: Information management | Standardization. General rules | Healthcare | Laboratory medicine | In vitro diagnostic test systems | Medical devices. Biological evaluation | Laboratory medicine. Other

Scope

This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination.

NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN ISO 6710.

NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test.

This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.

Purpose

This project has been already registered in June 2017 as an approved NP, but was "downgraded" to the PWI stage (ISO/PWI 6717) due to the missed deadline for providing the DIS manuscript. This proposal is to activate the existing PWI again.

Comment on proposal

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Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

02/01/2020

Proposal end date:

10/02/2020

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/TC 76 N 1325, ISO/PWI 6717 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

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