Ece 22.05 In Australia 734z6p

UNECE Regulation 22.05 Motorcycle Helmets in Australia Guy Stanford a and Tom Gibson b a Helmet Committee Australian Motor Cycle Council bHuman Impact Engineering humanIMPACTengineering injury prevention through analysis, testing and design

Introduction It is now possible to import, sell and use on the roads in Australia • UN/ECE Regulation 22.05 Protective helmets and their visors for drivers and engers of motor cycles and mopeds • AS/NZS 1698 Protective helmets for vehicle s.

3 Questions For the Australian consumer will the change produce • Safer helmets? • Simpler, more understandable regulation able to adapt to market change? • Cheaper helmets?

The ‘BEST’ Helmet Standard Cochrane Collaboration - Lui et al. (2009) • Reviewed available helmet effectiveness studies • Found that motorcycle helmets were – 45% effective in reducing fatality risk – 69% effective in reducing the risk of serious injury.

• But insufficient evidence to demonstrate whether differences in helmet type confer more or less advantage in injury reduction. • Hence, little value in comparing the technical attributes of helmets defined by the test requirements within the two standards.

AMC Review Other areas of the standards setting process• Responsiveness, adaptability and timeliness of the standard to changing helmet developments in the market . • The quality assurance regimes compared with ISO/IEC 17065 and ISO/IEC 17067 Conformity Assessment. • Cost for the consumer

Helmet Recalls - May 2013 • ACCC tested 6 helmets • Recalled helmets from 4 suppliers • All helmets Certified as compliant with AS/NZS 1698:2006 by different certifiers • The Australian Consumer Law 2011 requires “substantiation of compliance” – ACL at Schedule 2 of the Consumer and Competition Act 2010, applies nationally

Helmet standards contain specified requirements for a helmet

Conformity Assessment • Requires a Certification Scheme to prove the specified requirements are met • No Certification Scheme, then no information about the criteria with which the certified product complies. • Certification Schemes define the METHOD of assessing the specified requirements • Certification Scheme ensures conformity to specified requirements is assessed before it is placed on the market

Production Variability • A production process exhibits variability • The question is always “How Much?” • Mean and Standard Deviation are useful measures of variability when the distribution is normal or approximately normal • It allows a view of reliability or consistency

Production Variability

Mean = 262.9 SD = 38.9

Only 83% of production is in compliance

Production – Lowering the Mean

Mean = 200 SD = 38.9

Reducing impact test Mean by altering helmet design, but with same production variability, allows 99% of production to be compliant

Production– Reducing Variability

Mean = 262.9 SD = 15 Improved production process significantly reduces variability. 99% of production now compliant without changing helmet design

Statistical Sampling • Sampling can be statistically evaluated. • For a shipping container of say 1,000 helmets, and no knowledge of production variability, ISO 2859-2 (AS 1199-2) defines this as an “ISOLATED LOT” • AS 1199 specifies that for PROOF of 99.5% conformity, 380 helmets of the 1,000 are to be tested to ALL specified requirements - with no failures

Certification • ISO/IEC 17065 - Conformity assessment— Requirements for bodies certifying products, processes and services • Certification Bodies use their own Scheme • ISO/IEC 17065 does not contain detailed requirements on certification schemes. • Schemes typically include additional requirements above and beyond those outlined in ISO/IEC 17065

ISO 17000 - Conformity assessment— Vocabulary and general principles • A.1.1 Conformity assessment is a series of three functions that satisfy a need or demand for demonstration that specified requirements are fulfilled:

1. selection 2. determination 3. review and attestation.

1 –Selection (ISO 17000) • “Selection” is identifying WHAT needs testing at WHAT stage

1. Design stage (Type Test) 2. Production ready stage (Production Qualification) 3. On-going production surveillance (“batch testing”) •. Selection activities take place in both the initial assessment and in surveillance. •. However, entirely different choices might be made in surveillance.

2 & 3 – Determination, Review, Certification (ISO 17000) • Determination - testing • Review - verification of suitability, adequacy and effectiveness of selection and determination – that these activities fulfil requirements

• Certification – attesting to conformity with a standard – demonstration that specified requirements for a product are fulfilled

Certification Initial certification comprises :• Selection, Determination, Review, Attestation • PRIOR to marketing of product Maintaining Certification requires:• Surveillance – batch testing • Sampling from production and/or marketplace

UNECE Regulation 22-05 • Type Test (to prove the product design meets the standard) [Paras 6 & 7] • Production Qualification (to prove the production system is capable of producing successive compliant product)[Para 9.1] • Product Surveillance or “batch testing” (to prove that the on-going products are compliant) [Para 10.5.1]

AS/NZS 1698:2006 • Sets out specified requirements only • Does NOT deal with Conformity Assessment • All processes of a Certification Scheme are unique to each CAB, at their discretion.

Compliance Comparison Compliance Folder

ECE 22-05

AS/NZS 1698

Type Test Report

X

X

Qualification of Production

X

-

Certificate of Conformity

X

X

Production Surveillance Tests

X [Para 10.5.1.4]

X [varies by CAB]

Yearly Tests

X

X [varies by CAB]

Factory Audit Certificate

X

-

Conformity Audit Certificate

X

X

Component Quality Control

X

X

Batch Testing • Certification Schemes includes how the certified product can maintain its certification after initial certification is granted • Batch testing does not substitute for initial assessment of compliance • Batch Test sampling rates are low • Batch testing alone cannot determine compliance

AMC Impact Testing • Job-lot of discontinued AS/NZS Certified helmets • Type Test of Clause 6.1 of AS/NZS 1698:2006 – 6 helmets tested • Test to Clause 7.4 of AS/NZS 1698:2006 – 40 helmets tested – Results analysed by Clause 9 of ECE 22-05

Testing Results • AS/NZS 1698 Clause 6.1 – 6 helmets ed – BUT, when extras added (to test 10), one failed

• Clause 9 of ECE 22-05 requires 40 helmets to be tested. We tested 50 • Limits on Standard Deviation and Mean at Clause 9.2.2.3 of ECE 22-05 were exceeded • 5 helmets failed Clause 7.4 of AS/NZS 1698

AMC Testing Results – part 2 • This batch of helmets failed Production Qualification • Under ECE 22-05 certification criteria, this helmet would NEVER have reached the market • Certification requirements for AS/NZS 1698:2006 are comparatively weak. • Batch test sample rate by itself inadequate to detect failures

The 40 helmets when tested had: • • • • • •

1st Impact: Mean (X) of 203.15 Standard Deviation 2nd Impact:Mean (X) of 262.90 Standard Deviation

g (S) of 26.29 g g (S) of 38.90 g

• No test result exceeded 330 g (1.1xL) for the first impact • 3 test results exceeded 330 g for the second impact. •   •   • Under these conditions, the 40 helmets failed the ECE Reg 22.05 Clause 9.2.2 Shock Absorption production qualification test for the second impact.

• • • • • •

1st impact X + 2.4S = 266.25 does not exceed L 2nd impact X + 2.4S = 356.26 exceeds L.

• FAILED

1st Impact (AS/NZS 1698 Clause 7.4)

Mean = 203.15 SD = 29.29

2nd Impact (AS/NZS 1698 Clause 7.4)

Mean = 262.9 SD = 38.9

17% of production non-compliant

AUS Helmet Pricing • Pricing affected by:– Currency Fluctuation against US, EU – When ordered (18 month lead times)

• “Deals” such as – Bulk purchase – Superseded models – Alterations to meet AS/NZS

PRICES 2012 to 2016 2012 • Average over US retailer pricing around 65%

2016 • Average over US retailer pricing around 37%

• AS/NZS helmets essentially re-certified FMVSS-218

• Average over European retailer pricing around 20%

• EU€ • US$

Summary - 2 For the Australian consumer, the addition of UNECE Regulation 22.05 motorcycle helmets for sale and use on the road to AS/NZS 1698 helmets • Will produce simpler more understandable regulation • Cheaper and safer helmets.  

Summary - 2 Successful implementation will require • a means of proof of substantiation of helmet conformance with the provisions of Australian Consumer Law (ACL). • Need for surveillance testing of market helmets    

THANK YOU

In Memoriam – Tony Ellis

ISO 17065 – Normative Refs • ISO/IEC 17000 - Conformity assessment — Vocabulary and general principles • ISO/IEC 17020 - Conformity assessment — Requirements for the operation of various types of bodies performing inspection • ISO/IEC 17021 - Conformity assessment — Requirements for bodies providing audit and certification of management systems • ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories

Scheme Development References • ISO/IEC 17067 (Fundamentals for product certification schemes) • ISO/IEC Guide 23 (methods of indicating conformity) • ISO/IEC Guide 27 (corrective action for misuse of mark) • ISO/IEC Guide 28 (model for third party product certification systems) • ISO/IEC Guide 53 (use of quality systems) • ISO/IEC 17007 (drafting normative documents) • ISO/IEC 17030 (use of marks) • ISO/IEC 19011 (auditing Management Systems)

Table 1: ISO 17065 Building a product certification scheme Conformity assessment functions

Conformity assessment activities

Scheme types

Type 1 to Type 5 for product s