Enersol Pty Limited

Site

Enersol Pty Limited

Accreditation No.

11444

Site No.

11437

Date of Accreditation

28 Feb 1996

Address

235 Nelson Street
Annandale, NSW 2038
Australia

enersol.com.au

Contact

Ms Lisa Henretty P: +61 (02) 95521707

Availability

Services available to external clients

Scope of Accreditation

Enersol Pty Limited

ISO/IEC 17025 (2017)

Manufactured Goods

Service Product Determinant Technique Procedure Limitations
Performance evaluation of healthcare equipment and related items Female condoms Burst pressure; Burst volume; Leakage; Length; Thickness; Width Not applicable

ISO 25841,

WHO Female condoms Guidelines 2012

Hypodermic needles Bond between hub and needle tube; Cleanliness; Colour coding; Defects; Diameter; Evaluation of consumer information - Labelling and markings; Fragment production from rubber closures; Length; Limits for acidity and alkalinity; Lubricants; Package integrity; Patency of needle tube lumen Not applicable ISO 7864
Male condoms Burst pressure; Burst volume; Tensile properties Not applicable ISO 19671
Burst pressure; Burst volume; Evaluation of consumer information - Labelling and markings; Freedom from holes; Leakage; Length; Package integrity; Package seal; Tensile properties; Thickness; Total lubricant; Visible defects; Width Not applicable

ASTM D3492;

ISO 4074 all annexes except G;

ISO 23409;

 NZS 7106;

Dry package seal to in-house procedure UNFPA;

Package and materials markings to WHO Technical Report Series No. 1025-2020

Small-bore connectors for liquids and gases in healthcare applications Leakage; Resistance to overriding; Resistance to separation - Force; Separation of screwed closures; Stress crack resistance Not applicable ISO 80369-20
Syringes Air leakage past piston during aspiration; Barrel dimensions; Dead space; Liquid leakage past piston; Stress crack resistance; Unscrewing torque Not applicable ISO 7886 Parts 1,2,3 and 4;
ISO 594 Parts 1 and 2 (2016);
ISO 8537

The only data displayed is that deemed relevant and necessary for the clear description of the Activities and Services covered by the Scope of Accreditation (SoA).

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.

The Product column may also describe an Item or Material.

The Limitations column may also describe the Range.