Certificates

<p><strong>Certificates</strong></p>

Gehörschutz und Kommunikation

Certificates

Phonak’s devices are regulated globally by government agencies, healthcare authorities and other regulatory bodies. These organizations ensure that we comply with the requirements of the applicable health and safety regulations throughout the life cycle of our products.

We are committed to transparent, constructive and professional relations with all relevant regulatory bodies with regard to directives, product submissions, compliance and product performance. You can find the full text of the EU Declaration of Conformity for each product here.

Declaration of Conformity

Gehörschutz und Kommunikation

Declaration of Conformity

Roger Covert C
Security
pdf
719 KB
Roger Covert Dual C
Security
pdf
724 KB
Roger Covert RCU C
Security
pdf
723 KB
Roger Earpiece C
Security
pdf
707 KB
Profilo NANO AC DM
Security
pdf
738 KB
Roger Base Station
Studio
pdf
766 KB
Roger Earpiece
Studio
pdf
707 KB
Roger Repeater ComSys
Studio
pdf
708 KB
Roger (SF) Touchscreen Mic
Studio
pdf
714 KB
Invisity
Studio
pdf
707 KB
ComCom, ComCom Listen
Headset
pdf
688 KB
FreeCom 7000/7100
Aviation
pdf
773 KB
Dominator
Security
pdf
779 KB
Primero DPC
Security / Gehörschutz
pdf
2 MB
Serenity Classic
Gehörschutz
pdf
742 KB
Serenity SP / SPC
Gehörschutz
pdf
768 KB
Serenity DP / DPC
Gehörschutz
pdf
778 KB
Serenity Choice Shooting KIM 12
Gehörschutz
pdf
717 KB
Silemo mini
Gehörschutz
pdf
723 KB

CE certificates

Gehörschutz und Kommunikation

CE certificates

Serenity Classic
Gehörschutz
pdf
857 KB
Serenity SP
Gehörschutz
pdf
655 KB
Serenity SPC range
Gehörschutz
pdf
1 MB
Serentiy DP
Gehörschutz
pdf
655 KB
Serenity DPC range
Gehörschutz
pdf
655 KB
Serenity Choice Shooting KIM 12
Gehörschutz
pdf
495 KB
Primero DPC
Security / Gehörschutz
pdf
655 KB
FreeCom
Aviation
pdf
655 KB
Dominator
Security
pdf
1 MB
Silemo mini
Gehörschutz
pdf
2 MB

ISO certificates and directives

Gehörschutz und Kommunikation

ISO certificates and directives

ISO 9001:2015
pdf
498 KB
ISO 13485:2016
pdf
462 KB
ISO 14001:2015
pdf
469 KB
Environmental Policy
pdf
101 KB
Quality Policy
pdf
78 KB
Certificate Module D
pdf
700 KB

Statement for the new PPE regulation

Gehörschutz und Kommunikation

Statement for the new PPE regulation

On the 21 April 2018 the PPE Directive 89/686/EEC was repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment. 

Article 47 of the new Regulation 2016/425 foresees a specific transitional period of 1 year (21 April 2018 to 20 April 2019) where both, the old Directive and the new Regulation, are applicable. According to Article 47 (1), products which have been placed on the market before 21 April 2019 in compliance with the old Directive can continue to be made available on the market even after 21 April 2019.

Furthermore, Article 47 (2) lays down that EC type-examination certificates and approval decisions issued under the old Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date. All PPE products from Phonak Communications AG were placed on the market with EC type-examination and have valid EC type-examination certificates for conformity with the PPE Directive 89/686/EEC without expiration date before 21 April 2023. Our team is working on a re-certification schedule for obtaining EC type-examination certificates for compliance with the new Regulation 2016/425 in due time.