AcuPulseTM DUO Compliance with International Standards

EN/ISO 13485:2012 - Medical devices - Quality management systems - Requirements
for regulatory purposes

CE Directive 93/42/EEC - European Medical Devices Directive 93/42/EEC as amended
by 2007/47/EC

Directive 2002/95/EC - Restriction of Hazardous Substances (RoHS) Regulation

Directive 2002/96/EC - Waste Electrical and Electronic Equipment (WEEE) Directive

FDA 21 CFR, Part 820 - Code of Federal Regulations, Food and Drug- Quality System
Regulation

SOR/98-282-2012 - Canadian Medical Devices Regulations (CMDR) SOR/98-282

General Principles of Software Validation; Final Guidance for Industry and FDA Staff

ANSI/AAMI/IEC 62304:2006 - Medical device software - Software life cycle processes

EN/ISO 14971:2012- Medical Devices – Application of risk management to medical
devices

CFR 1040.10 & CFR 1040.11 – US Federal Performance Standards for Class IV Lasers

47 CFR Part18 – Industrial, Scientific & Medical Equipment

IEC 60601-1:1988- Medical electrical equipment - Part 1: General requirements
for basic safety – Second Edition (Amd.1:1991+Amd.2:1995+Cor.1:1995)

IEC 60601-1:2005 – Medical Electrical Equipment – Part 1: General Requirements for
Basic Safety and Essential Performance - Third Edition (Cor.1:2006+Cor.2:2007 )

EN 60601-1:2006- Medical electrical equipment. General requirements for basic safety
and essential performance

IEC 60601-1-2:2007 – Medical Electrical Equipment – Part 1-2: General Requirements
for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic
Compatibility – Requirements and Tests - Edition 3.0

IEC 60601-1-4:2000 – Medical Electrical Equipment - Part 1-4: General Requirements
for Safety - Collateral Standard: Programmable Electrical Medical Systems - Edition 1.1;
Edition 1:1996 Consolidated with Amendment 1:1999

IEC 60601-1-6 ed3.0 (2010-01)- Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-2-22:1995 – Medical Electrical Equipment Part 2: Particular Requirements
for Safety Section 2. 122: Specification for Diagnostic and Therapeutic Laser Equipment

IEC 60601-2-22:2007 – Medical Electrical Equipment – Part 2-22: Particular
Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic,
Therapeutic and Diagnostic Laser Equipment - Edition 3.0

IEC 60825-1:2007 – Safety of Laser Products – Part 1: Equipment Classification and
Requirements - Edition 2
Lumenis Ltd.
6 Hakidma St. POB 240
Yokneam, Israel 20692
T. +972-4-9599000
F. +972-4-9599050
www.lumenis.com

UL 60601-1:2003 – UL Standard for Safety Medical Electrical Equipment, Part 1:
General Requirements for Safety

UL 60601-1:2005 – UL Standard for Safety Medical Electrical Equipment, Part 1:
General Requirements for Safety

47 CFR FCC Part 15 —Radio Frequency Devices - Rules and regulations; Part 15
(Subpart B- Unintentional radiators ;Section 15.109- Radiated emission limits; C Intentional radiators (2009);Section 15.107- conducted limits)

RFID Security Information System - ETSI EN 300 330-1 V1.7.1 (2010-02) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices
(SRD); Radio equipment in the frequency range; 9 kHz to 25 MHz and inductive loop
systems in the frequency range 9 kHz to 30 MHz; Part 1: Technical characteristics and
test methods

RFID Security Information System - ETSI EN 300 330-2 V1.5.1 (2010-02) Electromagnetic compatibility and Radio spectrum Matters (ERM);Short Range Devices
(SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop
systems in the frequency range 9 kHz to 30 MHz; Part 2: Harmonized EN covering the
essential requirements of article 3. 2 of the R&TTE Directive

RFID Security Information System - CEPT/REC Recommendation 70-3 (May 2013)Relating to the use of Short Range Devices (SRD)

Requirements of Canadian Standards Association / National Standard of Canada are met
as per CSA Test Reports and Certificates

ISO 15223-2:2010 - Medical devices -- Symbols to be used with medical device labels,
labeling, and information to be supplied -- Part 2: Symbol development, selection and
validation

EN 980:2008 - Symbols for use in the labeling of medical devices

ASTM D5276-98 - Standard Test Method for Drop Test of Loaded Containers by Free
Fall

ASTM D4728 - 06(2012) - Standard Test Method for Random Vibration Testing of
Shipping Containers

ASTM D999 – 08 - Standard Test Methods for Vibration Testing of Shipping Containers
Lumenis Ltd.
6 Hakidma St. POB 240
Yokneam, Israel 20692
T. +972-4-9599000
F. +972-4-9599050
www.lumenis.com