| SERVICE | PRODUCT | DETERMINANT | TECHNIQUE | PROCEDURE | LIMITATION / RANGE |
Evaluation of products for infants and children
| Toys;
| Abuse - Compression evaluation; Abuse - Drop evaluation; Abuse - Tip over evaluation; Evaluation of expanding materials; Material quality; Pompoms dimensional compliance; Pre-school play figures dimensional compliance; Shape and size; Small balls; Small parts;
| Not applicable;
| AS/NZS ISO 8124.1:2002 clauses 4.1, 4.2, 4.3.1, 4.3.2, 4.4, 4.5.1, 4.5.2, 4.5.4, 4.5.5, 4.25 (a) (b) and (c), 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.20, 5.21, 5.23, 5.24.1, 5.24,2, 5.24.3, 5.24.5, 5.24.6.1, 5.24.6.2, 5.24.6.3, 5.24.6.4 and 5.24.7 as specified and required by Consumer Protection Notice No.14 (2003)
AS/NZS ISO 8124:1 2016 clauses 4.1, 4.3.1, 4.3.2, 4.4, 4.5.1, 4.5.2, 4.5.4, 4.5.5, 4.26 (a), 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.21, 5.24,2,5.24.3 and 5.24.7 | |
| Including Material, Mouth actuated toys, Pompoms, Preschool figures, Small parts, Squeeze toys, rattles, fasteners and similar toys and components of toys; Toy pacifiers
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Material performance evaluation of elastomers, plastics and composite products
| Hot water bottles;
| Capacity; Creep resistance for PVC hot water bottles; Leakage; Percentage (%) mass change for PVC hot water bottles; Pressure; Seam evaluation; Separation of screwed closures; Stoppers (closures); Tear strength; Tensile properties; Tension set; Thickness;
| Not applicable;
| BS 1970 (excluding ageing of hot water bottle samples);
Trade Practices (Consumer Product Safety Standard) (Hot water bottles) Regulations 2008;
Fair trading Amendment (Hot water bottles) Regulations 2009 | |
|
Performance evaluation of healthcare equipment and related items
| Male condoms;
| 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, ISO 23409;
NZS 7104, NZS 7106;
Dry package seal to in-house procedure UNFPA v3;
Package and materials markings to WHO 2010 Specification
| |
|
| Dams;
| Freedom from holes; Length; Mechanical strength; Tear strength; Tensile properties; Thickness; Width;
| Not applicable;
| AS 1683.12;
AS/NZS 4592 (excluding Section 4.1)
| |
|
| Intra-uterine contraceptive device (IUCD);
| Dimensions; Shape; Stability; Tensile properties; Visco-elastic memory;
| Not applicable;
| ISO 7439 Clauses 5.2, 5.3, 5.4, 5.5, 7.2, 7.3, 7.4 | |
|
| Microwaveable heat packs;
| Abuse - Reasonable foreseeable abuse; Evaluation of consumer information - Labelling and markings; Heat resistance of filling material; Surface heat resistance;
| Not applicable;
| AS/NZS 5116 clauses 4.2.1, 4.2.2, 4.2.3, 4.3.1, 4.3.2, 4.3.4, 4.4, 5 | |
|
| Type I catheter - With or without balloon; Type III catheter - With or without balloon;
| Catheter drainage eye shape; Catheter drainage lumen shape; Catheter free end (funnel end) shape; Catheter inflating tube examination - Moulded, non-return valve; Catheter tip position evaluation; Dimensions; Evaluation of consumer information - Labelling and markings; Finish; Flow rate; Length; Orientation; Package integrity;
| Not applicable;
| AS/NZS 2696:1996 (excluding Appendix B)
| |
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| Female condoms;
| Burst pressure; Burst volume; Leakage; Length; Thickness; Width;
| Not applicable;
| ISO 25841; WHO Female condoms Guidelines 2012
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| Hyperdermic 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;
| AS 1946 (excluding Section 6) | |
|
| Surgical gloves;
| Breaking force; Cuff rupture resistance; Leakage; Length; Residual powder; Thickness; Width;
| Not applicable;
| AS/NZS 4179;
ASTM D3577;
ISO 10282; ISO 21171;
| |
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| Tampons;
| Absorption; Applicator; Evaluation of consumer information - Labelling and markings; Length; Length of withdrawal cord; Package integrity; Pull strength of withdrawal cord; Water repellence of withdrawal cord;
| Not applicable;
| AS 2869 (excluding sections 5.4 and 8)
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| Syringes;
| Air leakage past piston during aspiration; Barrel dimensions; Liquid leakage past piston; Stress crack resistance; Unscrewing torque;
| Not applicable;
| AS 1600.1, AS 1600.2, AS 1094.1;
ISO 7886, ISO 594 | |
|
| Small-bore connectors for liquids and gases in healthcare applications;
| Dead space; Resistance to overriding; Resistance to separation - Force; Separation of screwed closures; Stress crack resistance;
| Not applicable;
| | |
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| Examination gloves;
| Cuff rupture resistance; Leakage; Length; Residual powder; Tensile properties; Thickness; Width;
| Not applicable;
| ISO 11193; ISO 21171; ASTM D3578; ASTM D6124; AS/NZS 4011
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Sample collection
| Rubber products;
| Not applicable;
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| ISO 2859
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