At Finch Healthcare, safety, quality, and reliability are at the core of every product we provide. All of our equipment is rigorously tested to meet or exceed Australian and international standards, ensuring compliance, durability, and clinical effectiveness. By adhering to recognised testing protocols, we deliver solutions that healthcare professionals and clients can trust.
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Mountain Trike (MT) |
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ARTG Number |
429750 |
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The Manual |
EN Standards 12182, 12183, 12184, 14971 |
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The Trike |
EN15194 AS EN 12182:2015 [Current] Assistive products for persons with disability — General requirements and test methods AS ISO 14971:2020 [Current] Medical devices - Application of risk management to medical devices |
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Electric Bike Rules |
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Cura Seating |
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ARTG Number |
288382 |
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The Chair |
AS/NZS 4688.2-2000 Part 2,3,4 |
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Metzeler Mattresses |
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ARTG Number |
363471 |
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Water Impermeability |
DIN EN 20811 |
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Flame Retardant |
DIN EN ISO 12952-1 & -2 BS 7175 BS 7175:1989 Section 3 |
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Water Vapour Permeability |
DIN 53122 / CLIMATE B |
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Biocompatible |
DIN EN ISO 10993-5 & -10 |
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Surgical Clothing and Drapes - Requirements and test methods |
UNI EN 13795 |
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
ISO 10993-10:2010(E) |
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Standard Protocol for Measuring Immersion of Full Body Support Surfaces Envelopment Heat & Moisture Dissipation Characteristics Sweating Guarded Hot Plate Method Support Surface Horizontal Stiffness |
ANSI/RESNA SS-1:2019 |
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Winncare Mattresses |
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ARTG Number |
363471 |
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EMDN Code & Term |
V080701 Active anti-bedsore medical mattresses |
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Risk Classification |
Risk Classification: Class I medical device according to the regulation (EU) 2017/745, Annex |
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Harmonised Standards Applied |
EN ISO: 13485:2016, 14971:2012, 15223-1:2016, 10535:2006 |
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Basic UDI-DI |
50564619DYN_PUP3N |
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Quality Management System |
ISO-13485-2016 |
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Safety Standards |
BS EB 60601-1:2006+A13:2024 |
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Biocompatibility Standards (Skin & Patient Contact) |
SO 10993 series — Biological evaluation of medical devices ISO 10993-1: Evaluation and testing within a risk management process ISO 10993-5: Tests for in vitro cytotoxicity ISO 10993-10: Tests for irritation and skin sensitization ISO 10993-23: Tests for irritation (skin and mucosal surfaces) |
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Infection Control & Hygiene |
ISO 16603 / ISO 16604 — Resistance of materials to penetration by blood and body fluids / blood-borne pathogens EN ISO 22610 — Resistance to wet bacterial penetration (commonly referenced alongside UNI EN 13795) EN ISO 22612 — Resistance to dry microbial penetration ISO 14272 (and related) — Cleanability and disinfectant resistance |
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Flammability Standards (Hospital Safety) |
BS 7175 — Flammability testing for bed mattresses and components used in hospitals (UK/NHS standard) Crib 5 / Source 5 test — Specific ignition resistance test (often cited in Australia & UK healthcare tenders) CAL TB 129 (California Technical Bulletin) — Full-scale flammability test for mattresses EN 597-1 & EN 597-2 — Smouldering cigarette and match flame tests |
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Performance & Durability |
SO 12947 (Martindale Test) — Abrasion resistance of fabrics ISO 811 — Hydrostatic head test (liquid barrier performance) ISO 14126 — Protective clothing against infective agents (often adapted for mattress covers in clinical use) EN 13795 (for surgical textiles, sometimes referenced in infection-barrier bedding) |
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Anatomic Sitt - Starfish Commode |
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ARTG Number |
178577 |
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Standards |
Class I medical device under the EU Medical Device Regulation (EU MDR 2017/745, Annex VIII) |
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Toileting for people with disabilities |
AS/NZS 3973 |
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Wheelchair/commode performance & safety |
AS/NZS ISO 7176 series |
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Medical device compliance basics |
AS/NZS 13485, 14971, 10993 |
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Fire safety of soft parts |
AS/NZS 1530.3 |
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Cleaning/reprocessing in clinical settings, if reused in hospitals |
AS/NZS 4187 |
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Harmonised Standards |
EN ISO 21856:2022 EN ISO 14971:2020 EN ISO 15223-1:2016 |