Standardisation and certification of smart personal protective equipment
Smart personal protective equipment (PPE) offers a wide range of novel applications and increased levels of protection. The same is true of smart personal protective systems (PPSs) and PPE ensembles (KANBrief 1/16) . The development of smart technologies is on the rise; however, companies are still struggling to market the products in series production quantities. A joint initiative by research institutions and manufacturers’ federations aims to increase the efficiency of development and conformity assessment of smart PPE and PPSs.
Many smart systems developed to date have not yet found their way onto the market owing to the complexity of conformity assessment (i.e. certification) compared to traditional PPE. Furthermore, end users’ requirements (and concerns) have not yet been sufficiently addressed with regard to which smart functions have the potential to improve their safety most effectively. A critical field of discussion concerns the ethics, safety and security of data. How and by whom should the user‘s health data be processed, and for how long should such data be stored? What requirements must be met with regard to care and maintenance of an item of smart PPE or a PPS? Does the user change his or her behaviour when equipped with an intelligent garment or system, and do new risks arise due to such changes in user behaviour? As these as-yet unanswered questions are strongly linked to product liability, notified bodies (NBs) and manufacturers alike appear to be proceeding very cautiously in the field of smart PPE.
The fact that only few standards exist for products or systems of this type is certainly a factor adding to the complexity of conformity assessment. In 2017, the European Commission issued a standardisation request for advanced garments and ensembles of garments providing protection against heat and flame and employing integrated smart textiles and non-textile elements. The work entailed by this standardisation request is being coordinated by the CEN-CENELEC PPE sector forum and is progressing well. Publication of a first Technical Report specifying terms and definitions is expected for the second half of 2019, while a Technical Report on Selection, Use, Care and Maintenance (SUCAM) is expected for publication before the summer of 2020. Both of these documents will be useful for all types of smart PPE and PPSs. A standard setting out product requirements is also being developed and is anticipated for the end of 2021. As a follow-up to a workshop organised at CEN-CENELEC on the topic of standardisation for smart PPE/PPSs in September 2017, a second workshop is scheduled for 14 October 2019 at which all stakeholders are invited to share their experiences and concerns.
To provide users, the industry and the NBs with a basis for decisions, the unresolved issues must be addressed in an interdisciplinary format. We intend to use surveys and interviews in order to obtain the views of different stakeholder groups.
Companies from a number of countries have already responded. Around 85% of these companies are active in the field of smart PPE and PPSs; the remainder supply PPE ensembles. According to the respondents, approximately 46% already supply products in this innovative field. A similar number of companies are currently at the development and/or conformity assessment phase for their smart PPE and PPSs.
The costs and time entailed by development and conformity assessment must be regarded as “challenging”: it typically takes between 12 and 24 months (16 months on average) to develop smart PPE or PPSs. The costs of this development phase range from € 50,000 to € 250,000 (average: € 110,000). The duration of conformity assessment (i.e. the certification phase) ranges from 6 to 24 months (average: 9 months). The cost of this phase lies between € 10,000 and € 25,000 (average: € 20,000). Some companies stated that the cost and duration of conformity assessment even exceeded € 50,000 and 24 months.
As complexity of a product increases, the costs and time entailed by its development and conformity assessment will of course increase correspondingly. Nevertheless, nearly half of the respondents involved in smart PPE and PPSs are small or medium-sized enterprises (SME).
We aim to investigate further the scope for increasing the efficiency of development and conformity assessment of smart PPE and PPSs. We invite further companies to participate in our survey
www.surveymonkey.de/r/GWHTBSM. We intend to use the information gathered to support the establishment of a guidance document/roadmap for certification of innovative PPE/PPSs. Our next steps include the publication of surveys for the assessment of the NBs’ and end-users’ perspectives.
Jan Vincent Jordan (RWTH Aachen/ITA)
Henk Vanhoutte (European Safety Federation)
Karin Eufinger (Centexbel)
Daniela Zavec (Titera)