At AppleSyringe, with our objective of continuous product excellence, we focus on quality at all phases of design and production. Behind the flexibility of our products lies a 360 degree focus on quality. We have the following certifications:

In order to achieve effective infection control for intradermal, subcutaneous and intramuscular needle injections, WHO recommends the use of single-use injection devices. Single-use injection devices include single-use syringes used in conjunction with single-use needles, auto-disable (AD) syringes originally designed specifically for immunization, and syringes with a reuse-prevention feature for general purpose. In support of these recommendations, UNFPA, UNICEF and WHO have stated that, by the end of the year 2003, all countries should only use auto-disable (AD) syringes for immunization.

The PQS system (Performance, Quality, Safety). All existing PIS performance specifications and test procedures are currently under review and new PQS-compatible documents will be published during 2006 and 2007. In addition to covering immunization-related equipment, the new system has been extended to cover the majority of commonly used single-use injection devices – including devices used for therapeutic purposes. The PQS system will evaluate products and devices against the new documents; those that conform will immediately be listed as pre-qualified products on the PQS web page at:

http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=37

http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/categorypage.aspx?id_cat=42

 

0.5 ML Destroject WHO PQS Certificate

0.5 ML K1 WHO PQS Certificate

2 ML APPLE K1 WHO PQS Certificate

5 ML Apple K1 WHO PQS Certificate

 

 

 ISO 13485: 2003 EN ISO 13485 : 2012 (Click to View)

Medical devices – Systems Quality Management
Requirements for regulatory purposes

 DIRECTIVE 93/42/EEC (Click to View)

CE marking for medical devices

 ISO 9001 : 2008 (Click to View)

Quality Management System (QMS)

 ISO 14001 : 2015 (Click to View)

Environmental Management System (QMS)

OHSAS 18001 : 2007 (Click to View)

Occupational Health and Safety Standard