Regulations that may surprise you

Regulations that may surprise you EU POP, Australia Asbestos, Canadian Prohibition, and Brazil Medical Eco Design Presented by: Bruce Calder VP Consulting Services

Overview - Agenda Introduction Australia Asbestos Requirement Risk Testing EU POP SCCPs Recalls Canada Prohibition Overview and requirements Brazil EN 60601-1-9 Medical devices Summary and Q&A Webinar is 50 minutes with 10 minutes of Q&A (hopefully)

Claigan - Testing Laboratory Claigan has the highest volume product testing laboratory in North America for RoHS 2 & 3 REACH SVHC and Article 67 California Proposition 65 EU Persistent Organic Pollutants Australia Asbestos Canadian Prohibition of Certain Toxic Substances EN 60601-1-9 Let us help you.

Claigan - Update Services Monthly or Quarterly Updates - Custom webinar - On the changes in requirements - Impacts to your specific products - Monthly or Quarterly - Interactive

Australia Asbestos Brokers of products imported into Australia need objective evidence from manufacturers before identifying that a product does not contain asbestos - As of October 2016 - Related to the investigation by Australian border services that brokers were just checking the box on asbestos Failure to provide evidence to the broker results in the inability to import

Australia Asbestos Objective evidence - Importers must provide sufficient assurance to demonstrate that imported goods do not contain asbestos. Examples - Test report, or - Risk assessment, or - Quality procedures and processes Key metric - sufficient assurance to ensure proper due diligence was conducted by the importer or manufacturer

Risk Materials for Asbestos Fibrous materials - Fibre gaskets - Woven or braided cable jackets - Cable insulation fibre

Risk Materials for Asbestos Talc based materials - Asbestos and talc are virtually identical - Asbestos is commonly found as a contaminant in talc Examples - Electrical cable sheaths (fire resistant) - Cable powder (lubricant of insert wire in sheath)

Asbestos Testing Polarized Light Microscopy (PLM) Testing - Effective for fibre testing - Not effective for asbestos in talc Transmission Electron Microscope (TEM) Testing - Works for both fibre and talc - More expensive than PLM

UN - Persistent Organic Pollutants Persistent Organic Pollutants are banned under the UN Stockholm Convention (2001) - Starting 2004 However, - Legislative restriction will come from countries (or similar entities such as the EU) For POPs in articles - Specific POPs are banned unless incidental or trace in the article Legislative restrictions - Will ban a POP substance in articles except if trace - Will later identify a ppm level that represents trace

Addendum EU Persistent Organic Pollutants Regulation (EC) No 850/2004 Updated in November by Regulation 2015/2030 #1 cause of EU product recalls (related to restricted materials) Primarily in cheap PVC or vinyl New specification (November 2015) Articles containing SCCPs in concentrations lower than 0,15 % by weight shall be allowed No exemption for medical devices

SCCP Typical Recall - 2016 Roughly 2 to 3 recalls per week All above 0.15% Example below

POP - Short Chain Chlorinated Paraffins Another SCCP Recall - January 2016 - Power cable

SCCP - Recalls - EU

POP Failures at Claigan SCCP Failures - Short Chain Chlorinated Paraffins - Combination plasticiser and flame retardant Declarable under REACH SVHC, Prop 65 and restricted under POP >.15% All three samples are recent and contained >.5% SCCPs

SCCPs - Canada Limited to 0.15% w/w in the EU Also banned in Canada - Under the name short-chain chlorinated alkanes - Unless incidental - Which seems to be below 0.5% w/w of a manufactured item However, little enforcement has ever been observed

Canada - Prohibition of Certain Toxic Substances Prohibition of Certain Toxic Substances Regulations, 2012 - Also known as the most confusing restricted materials legislation on planet earth

Canada - Examples The rest of the world - Short Chain Chlorinated Parafins (SCCPs) Canada - Chlorinated alkanes that have the molecular formula CnHxCl(2n+2-x) in which 10 n 13

Canada - Examples EU - Member States shall ensure that, from 1 July 2006, new electrical and electronic equipment put on the market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE). Canada - (1) Subject to sections 5 and 9, a person must not manufacture, use, sell, offer for sale or import a toxic substance set out in Schedule 1 or a product containing it unless the toxic substance is incidentally present. - (2) Subsection (1) does not apply to a product that is a manufactured item that is formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design, if a toxic substance set out in Part 2 of Schedule 1 is present in that product.

Canada - Prohibition of Certain Toxic Substances Substances prohibited unless incidental or trace (mostly) - hexabromocyclododecane (HBCD); - perfluorooctanoic acid, its salts, and its precursors (PFOA); - perfluorocarboxylic acids, their salts, and their precursors (LC-PFCAs); - polybrominated diphenyl ethers (PBDEs); - perfluorooctane sulfonate, its salts and its precursors (PFOS). - Mirex - PBB - PCTs - Bis(chloromethyl) ether - Chloromethyl methyl ether - (4-Chlorophenyl) cyclopropylmethanone, O-[(4-nitrophenyl)methyl] oxime - N-Nitrosodimethylamine, - Hexachlorobutadiene, - Dichlorodiphenyltrichloroethane (DDT), - Hexachlorobenzene - Polychlorinated naphthalenes, - Tributyltins - SCCPs.

Canada - And the fun continues Many of the substances are not restricted in manufactured items (articles) - The manufacture, use, sale, offer for sale, or import of PFOA and LC- PFCAs are prohibited unless the substances are present in manufactured items. - The scope of the existing prohibitions for PBDEs is expanded to cover all PBDEs (including decabde) unless present in manufactured items. Or are very likely to be in articles - Mirex - PBB - HBCDD (except in construction foam) - Tributyltin

Canada - and continues But we could check the guidance - hahahahahaha Or the FAQ - Keep trying.

Canada Prohibition - Summary In practice, the following substance is banned in manufactured items (articles) - SCCPs unless incidental or trace which looks to be 0.5%. Maybe.

Requirement in Brazil - IEC 60601-1-9 As of December, 2016 EN Standard: Medical Electrical Equipment Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design Specific requirements are Sections 4.1, 4.5.2 and 4.5.3 INMETRO approval required.

IEC 60601-1-9 Section 4.1 - Identification of Environmental Aspects Establish process to identify environmental aspects across all life cycle stages. Examples include: Use of hazardous substances Emissions to air, water Waste, especially hazardous substances Noise, vibration, odour, dust, electromagnetic fields, etc. Transport (goods and employees) Proof: Process documentation, design documents demonstrating completion of identification

IEC 60601-1-9 Section 4.5.2 - Instructions for minimizing Environmental Impact during Normal Use Instructions to be provided in Accompanying Documents to minimize environmental impact during Expected Service Life Installation, use and maintenance Consumption of energy, consumable materials/parts, disposables, water, gasses, chemical reagents, etc. during normal use Emissions during normal use (e.g. waste water, waste consumable materials, acoustic energy, heat, gasses, vapours, particulates, hazardous substances and other waste) Locations of hazardous substances, radioactive sources, and induced radioactive materials Proof: Instructions are contained in Accompanying Documents Accompanying Documents - E.g. Instructions for use, safety instructions, etc. The Accompanying Documents may be provided electronically.

IEC 60601-1-9 Section 4.5.3 - Information for End of Life Management {Essentially, WEEE Treatment Instructions} Make available to Responsible Organization i.e. hospital, clinician or layperson responsible for use & maintenance of the medical equipment Make available to treatment facilities, as required Contain the following information: Location of components & parts that contain stored energy or pose other hazards Identification and location of Hazardous Substances requiring special handling and treatment Disassembly instructions sufficient for the safe removal of hazardous substances (including radioactive sources, etc.) Methods for controlling risks to disassemblers Proof: Availability of document with required content.

IEC 60601-1-9 - In Practice Section 4.5.1 - Identification of Environmental Aspects - Checklist review of design process against options Section 4.5.2 - Instructions for minimizing Environmental Impact during Normal Use - Checklist review of customer document against options Section 4.5.3 - Information for End of Life Management - EU WEEE Instructions for Treatment Facilities

Claigan - Update Services Monthly or Quarterly Updates - Custom webinar - On the changes in requirements - Impacts to your specific products - Monthly or Quarterly - Interactive