Standards News.

New standards
Draft standards
Work programmes of interest
Glossary

New Standards

Dec 1999

EN 455-3, "Medical gloves for single use - Part 3: Requirements and testing for biological evaluation " has just been published (Dec 1999).
It includes test methods for protein and endotoxin testing of gloves, as well as requirements for labelling covering protein content and powder.
Draft ISO standards have been published covering transfusion and infusion equipment for use with pressure infusion apparatus. They include infusion sets (ISO/CD 8536-8), fluid lines (ISO 8536-9), accessories for fluid lines (ISO 8536-10), and infusion filters (ISO/CD 8536-11). Comments on this early draft should be submitted by 10th Feb 2000.
Latest developments on the European standard for theatre gowns and drapes.

May 1997

The following medical device related European standard has recently been published:

BS EN 1281-1:1997 - Anaesthetic and respiratory equipment - conical connectors. Part 1 - cones and sockets.
The standard specifies dimensional and gauging requirements for cones and sockets, and performance requirements for latching connectors intended for use in medical devices, eg: breathing systems, anaesthetic gas scavenging systems, and vaporizers.

March 1997

The following medical device related European standards were published recently. They will be adopted as British Standards in due course.

EN 1617 - sterile drainage catheters and accessory devices for single use.
This standard covers the requirements for sterile, single use drainage catheters, wound drainage systems and components thereof designed for drainage of fluid to the exterior by means of gravity or negative pressure. It does not apply to catheters < 2mm OD, suction catheters for use in the respiratory tract (see prEN 1733), tracheal catheters/tubes (see prEN 1782), or urinary tract catheters (see EN 1616).
The requirements cover resistance to deformation, force at break, freedom from leakage, impact resistance, biocompatibility, sterility, corrosion tests and labelling.
EN 1615 - sterile enteral feeding catheters and giving sets for single use.
This European standard specifies reuirements for sterile single use enteral feeding catheters, enteral feeding sets and their connection systems. It does not apply to enteral feeding catheters in which the external diameter of the tube is greater than 7mm or to gastro-intestinal catheters primarily intended for the administration of medication.
The requirements cover the luer connectors, tensile strength, security of connections, leakage, biocompatibility, corrosion tests, colour code, and labelling.
EN 1618 - catheters other than intravascular catheters - test method for common properties.
This European standard specifies test method for common properties for catheters as they refer to the device ready for clinical use. It is not applicable to intravascular catheters.
The test methods cover corrosion resistance, tensile properties, leakage, flow rate, and security of connectors.

ISO/DIS 11810 - Draft international standard for Lasers and laser-related equipment - Surgical Drapes and patient protective covers suitable for use with lasers was published for voting on 24th September 1998. Voting terminates on 24th March 1999.

The standard covers 3 aspects of drapes used in laser surgery:

Laser induced flammability
Resistance to laser penetration
Reflectance

The standard does not cover other aspects for gowns and drapes - see the work on the draft European Standard for further details.

August 1997

ISO/DIS 13926-2 - Draft international standard for "Pen systems - plungers and discs for pen-injectors for medical use." was published for comment on 25th June 1997. This deals with plungers and discs for insulin pen systems, and covers dimensions, material, physical requirements, chemical requirements, biological requirements, and marking. The appendices contain a test for fragmentation, leakage test, and a test for sliding characteristics.

Comments to be in by 30th September, 1997.

Copies of the draft available from BSI for UKP 7.50. Tel: 0181-996-7000.

Work programmes of interest

Gowns and Drapes.

A European committee (CEN/TC 205/WG14) has been set up to develop standards for disposable and re-useable gowns and drapes. The Swedish standard has been for gowns and drapes has been used as the basis for the discussions.

A UK technical committee (TCI/100) has been shadowing the CEN work in the UK for the last 2 years, but a formal BSI committe is in the process of being set up.

In addition, the EEC is funding a research programme named "BIOBAR", whose aim is to develop test methods for the evaluation of barrier materials for protection against biological hazards (liquids and aerosols). BIOBAR is not related to the CEN/TC 205/WG14 work, even though the results of their research will be highly relevant to that committee. BIOBAR is expected to report by the year 2000.

The timescales for CEN/TC 205/WG14 are similar (reporting by 1999/2000).

Heat and moisture exchange filters.

CEN/TC 215 WG4 is developing standards for filtration efficiency of heat and moisture exchange filters. The test methodology is similar to that published by Duberstein and Howard

%A R. Duberstein
%A G. Howard
%T Sterile filtration of Gases: A bacterial aerosol challenge test.
%J Journal of the Parenteral Drug Association.
%D 1978
%V 32(4)
%P 192-198

but uses Collinson nebulisers, which I understand are *very* expensive. Porton Down have a version of this rig working in the UK.

glossary

EN: European Standard
prEN: Draft European Standard
BSI: British Standards Institute
ISO: International Standards Organisation
CEN: European standards organisation.
BS: British Standard
CEN/TC: CEN Technical Committee
WG: Working Group

This site was originally set up with the aid of sponsorship from the Value for Money Unit, Welsh Office and an educational grant from Sophos Convatec.