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Presented by:Bruce CalderVP Consulting Services
Regulations that may surprise youEU POP, Australia Asbestos, Canadian Prohibition, and Brazil Medical Eco Design
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’
AddendumEU 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
• Roughly 2 to 3 recalls per week• All above 0.15%
• Example below
SCCP Typical Recall - 2016
POP - Short Chain Chlorinated Paraffins• Another SCCP Recall
- January 2016
- Power cable
SCCP - Recalls - EU
SCCP - Recalls - EU
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
• 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
SCCPs - Canada
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.
• 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.
Requirement in Brazil - IEC 60601-1-9
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
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.