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.

• bruce.calder@claigan.com